Penile sleeve devices and penile stocking insert and methods of making the same

ABSTRACT

A penile sleeve device (PSD) that is an implantable subcutaneous penile shaft silicone rubber apparatus which has several functions such as to elongate, thicken, harden, straighten and custom shape a penis. The PSD has an elongated main component of stretchable elastic silicone elastomer into which an inner component of a much higher durometer silicone rubber material is positioned to provide the PSD with some rigidity. The main component is the only portion in contact with the penile shaft since the inner component resides within a pocket of the main component that is formed by two layers therein. The outside surface of these layers may include folds to assist in enhancing penile girth and lengthening. A penile stocking insert is also provided for increasing the length of the penis it is flaccid or erect state using an elongated tubular body constructed from an elastic material which applies a compressive force around the penile shaft, thus elongating the length of the penis.

BACKGROUND OF THE INVENTION

The present invention relates to penile implants and more particularlyto an implantable sub-cutaneous penile sleeve device (PSD) that serves aplurality of functions such as elongating the penile shaft in theflaccid and/or erect states, increasing penile girth in both states,hardening/increasing penile firmness, straightening a curved penis, andcustom-shaping a penis. A penile stocking insert is also disclosed forelongating the length of the penis in the flaccid and/or erect states.

The flaccid penis retracts under certain circumstances, perhaps mostnotably in cold environments, upon vigorous exercise, and uponelicitation of the “fight or flight” response. Penile retraction is dueto the emptying of blood resulting in volume reduction, the contractionof the dartos muscle, and the retraction or recoiling of the collagen,elastic, and muscle fibers in the penile tissue during the erect toflaccid state transition. Retraction of the penis results in asignificant volume decrease in the apparent size of the penis, which canbe a source of embarrassment to one undergoing penile retraction,especially in gym locker rooms, public showers, in the presence of theirsexual partner, and the like. Therefore, it is desirable to preventpenile retraction in order to not only avoid potential embarrassment,but to also improve confidence and self-esteem.

Currently there are medical and surgical treatments for erectiledysfunction (ED). When medical treatments fail to provide addedfirmness, such as VIAGRA® or similar oral medications, or injectable EDmedications, etc., then there are surgical options such as having animplant placed deep into the penis.

Implant devices are typically considered when patients have moderateerectile dysfunction. There are two types of implant devices, the metalrod type, and the balloon pump type, as shown in U.S. Pat. No. 3,987,789(Timm, et al.) and U.S. Pat. No. 5,167,611 (Cowan, et al.),respectively. Both of these devices are placed directly into the corporacavernosa CC (see FIGS. 8C and 8E; under general anesthesia and withdeep cutting into the penile tissues) resulting in extensive tissuedamage to the fine sinusoidal architecture of the cavernosa CC. Thissinusoidal architecture is designed to receive and hold blood in thenormal corpora cavernosum, thereby maintaining a natural erection. Afterplacement of these implant devices, there is no turning back because thetissue damage caused by the insertion of these implant devices ispermanent, and now the patient will be totally reliant on this internaldevice for erections. These surgical implant options, in perspective,are reasonable remedies, even with the tissue damage, since there istotal or near total erectile malfunction of the penis with all medicaloptions exhausted. In addition to the tissue damage sustained by theinsertion of the implant device, the balloon implants can malfunction.These balloon implant types are composed or many parts, valves, fluidreservoirs, etc., and may not only malfunction but simply “break”. Ifthe implant device were to malfunction, and they inevitably will, theywould then need to be replaced, thereby requiring another operation andexposing the patient, again, to the same risks of infection, anesthesia,etc. Lastly, the balloon and metal rod type implants are limiting, onlyproviding erection support to the penile shaft. These devices do nottake into consideration certain medical safety issues with high tensionsituations and potential tissue trauma, such as high direct pressure onthe glans causing the balloons or rods to press up (an under) the glanstissue causing possible trauma and tearing of tissues. The current PSD20 design will allow to treat low to moderate level ED, eliminating therisks of major tissue trauma from rod or balloon placement, delayindefinitely this major surgical step in treatment, and can, if neededor desired, easily reverse and remove this PSD 20 without permanentdamage.

U.S. Pat. No. 9,877,835 (Loria) discloses a penile insert device thatcan increase the length of a penis in its flaccid or erect state andwhich uses a plurality of alternating lateral plateaus and lateralvalleys to effect the change of penis length.

Other examples of penile implant structures are set forth in U.S. Pat.Nos. 5,445,594; 5,669,870; 5,899,849; 6,475,137; 6,537,204; and8,986,193 by Elist. However, in some cases, the structures disclosedtherein are of a very high durometer, or hardness, and with minimal tono flexibility. This device is in direct contact with penile tissueswhich can result in creating pressure points. These structures cantransmit stress directly to the penis glans and sub-glans tissues whichmay result in irritation, inflammation, skin erosion, tenderness andpain and possibly may even rupture the device through the skin.

Thus, there remains a need for a penile insert device that serves aplurality of functions in effecting enhancements to penile length,girth, appearance, feel, and providing safer low to moderate levelerectile dysfunction remedies, while avoiding the creation of pressurepoints that can result in patient pain and discomfort.

All references cited herein are incorporated herein by reference intheir entireties.

BRIEF SUMMARY OF THE INVENTION

A penile sleeve device configured for implantation in the subcutaneousspace of a patient's penis for enhancing or correcting penis shape andsize, treating low to moderate level erectile dysfunction, or correctingpenis curvature or malformation is disclosed. The penile sleeve devicecomprises: an elongated tubular section comprising a flexible elastomerfor maintaining the penis outstretched in a flaccid or erect state,wherein the elongated tubular section has a proximal end flange,configured for positioning near the pubic bone, and has a tapered distalend, configured for positioning adjacent the glans of the penis, andwherein the elongated tubular section is configured to be positionedaround the penile shaft in the subcutaneous space of the patient'spenis.

A method for forming a penile sleeve device configured for implantationin the subcutaneous space of a patient's penis for enhancing orcorrecting penis shape and size, treating low to moderate level erectiledysfunction, or correcting penis curvature or malformation is disclosed.The method comprises: forming an elongated tubular section from aflexible elastomer for maintaining the penis outstretched in a flaccidor erect state, and wherein the forming further comprises forming anflange, configured for positioning near the pubic bone, on a proximalend of the elongated tubular section while forming a tapered portion,configured for positioning adjacent the glans of the penis, on a distalend of the elongated tubular section.

A method for enhancing penis shape or to correct penis shape dysfunctionby implanting a penile sleeve device in the subcutaneous space of apatient's penis is disclosed. The method comprises: (a) degloving thepenis by surgically exposing the subcutaneous space of the patient'spenis by cutting the penile shaft skin at the circumcision line,revealing the penile shaft; (b) obtaining measurements of the penileshaft during an induced erect penile state and well as during a flaccidstate to form “penile measurements”; (c) forming a first elongatedtubular section comprising a flexible elastomer based on the penilemeasurements for maintaining the penis outstretched in a flaccid orerect state, wherein the first elongated tubular section comprises alongitudinal pocket formed between an inner layer and an outer layer ofthe elongated tubular member and wherein the first elongated tubularsection also comprises a first plurality of suture slits; (d) forming anelongated open-tubular section, based on the penile measurements,comprising a high durometer silicone rubber material or a metalmalleable alloy for providing hardness feature to the penile sleevedevice, wherein the elongated open-tubular section has a secondplurality of suture holes that are configured to align with the firstplurality of suture holes when the elongated open-tubular section isinserted within the longitudinal pocket to form the penile sleevedevice; (e) inserting a working end of a delivery device into anaperture within a dorsal side of the elongated open-tubular device, andwherein the aperture is accessible via a dorsal mid-line slit in theouter layer; (f) positioning a glans gripper device through a tubulartunnel in the penile sleeve device; (g) orienting a first end of thepenile sleeve device to be aligned with the penis glans and manipulatingthe glans gripper device to grasp the penis glans; (h) sliding thepenile sleeve device onto and over the penis glans using the deliverydevice which is driven towards the pubic area while the glans gripperdevice pulls the penis glans in the opposite direction, until a proximalend flange of the penile sleeve device is positioned in the pubic pocketspace near the pubic bone/ligament area and a tapered distal end of thepenile sleeve device is positioned adjacent the coronal rim of the penisglans, at which time the delivery device is disengaged and removed andthe glans gripper device releases the penis glans; (i) inserting amarking instrument through the aligned plurality of suture slits to markon the penile tissue the location of suture points; (j) rolling back thetapered end of the penile sleeve device and then inserting suturesthrough the plurality of suture slits in the penile sleeve device andinto the Tunica Albuginea and up through the plurality of slits; (k)unrolling the tapered end of the penile sleeve device and tying thesutures to secure the penile sleeve device to the penis; (l) reglovingthe penis by restoring the penile shaft skin along the penis shaft andconnecting the skin at the circumcision line using sutures.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale, emphasis instead being placed upon clearlyillustrating the principles of the present disclosure. Moreover, in thedrawings, like reference numerals designate corresponding partsthroughout the several views.

FIG. 1 is an isometric of the penile sleeve device (PSD);

FIG. 1A is a side view of the PSD of FIG. 1;

FIG. 1B is a cross-sectional view of the PSD taken along line 1B-1B ofFIG. 1A;

FIG. 1C is a cross-sectional view of the PSD taken along line 1C-1C ofFIG. 1A;

FIG. 1D is a cross-sectional view of the PSD taken along line 1D-1D ofFIG. 1A;

FIG. 1E is a cross-sectional view of the PSD taken along line 1E-1E ofFIG. 1A;

FIG. 1F is a cross-sectional view of the PSD taken along line 1F-1F ofFIG. 1A;

FIG. 1G is a cross-sectional view of the PSD taken along line 1G-1G ofFIG. 1A;

FIG. 1H is a cross-sectional view of the PSD taken along line 1H-1H ofFIG. 1A;

FIG. 1I is a cross-sectional view of the PSD taken along line 1I-1I ofFIG. 1A;

FIG. 1J is a cross-sectional view of the PSD taken along line 1J-1J ofFIG. 1A;

FIG. 1K is a cross-sectional view of the PSD taken along line 1K-1K ofFIG. 1A;

FIG. 1L is a front view of the PSD of FIG. 1A;

FIG. 1M is a back view of the PSD of FIG. 1A;

FIG. 1N is a side view of the PSD of FIG. 1A;

FIG. 1O is the other side view of the PSD of FIG. 1A;

FIG. 1P is a top view of the dorsal side of the PSD of FIG. 1A;

FIG. 1Q is a bottom view of the ventral side of the PSD of FIG. 1A;

FIG. 2 is another isometric view of the PSD of FIG. 1A;

FIG. 2A is a cross-sectional view of the dorsal slit depicting how theslit forms a tongue-groove closure to maintain any liquids within thePSD;

FIG. 2B is side view of the PSD showing a lateral slit is opened toexpose the suture slits;

FIG. 2C is an enlarged view of the opened lateral slit of FIG. 2Bexposing the suture slits;

FIG. 2D is a view similar to the view of FIG. 2C but including thesuture clips installed in the suture slits;

FIG. 2E is a cross-sectional view of one of the installed suture clip,taken along line 2E-2E, showing a suture secured to the penile shaft andaround the suture clip;

FIG. 2F is a plan view of one of the installed suture clips shown inFIGS. 2D-2E;

FIG. 2G is cross-sectional view of the PSD showing the internalcomponent positioned inside the pocket of the main component;

FIG. 2H is a partial break-away side view of the PSD showing a portionof the internal component within the main component;

FIG. 2I is a cross-sectional view of the PSD implanted over the penileshaft and taken along a line similar to 1H-1H of FIG. 1A;

FIG. 2J is a cross-sectional view of another PSD embodiment, referred toas “PSD-wavy fold”, implanted over the penile shaft and taken along aline similar to 1H-1H of FIG. 1A;

FIG. 2K is a cross-sectional view of another PSD embodiment, referred toas “PSD-S fold”, implanted over the penile shaft and taken along a linesimilar to 1H-1H of FIG. 1A;

FIG. 2L is a cross-sectional view of another PSD embodiment, referred toas “PSD-Tight-S” fold, implanted over the penile shaft and taken along aline similar to 1H-1H of FIG. 1A;

FIG. 3 is an isometric view of the internal component of the PSD;

FIG. 3A is an end view of the internal component in an uncompressedstate;

FIG. 3B is an end view of the internal component in an inwardlycompressed state;

FIG. 3C is an alternative internal component whose initial state is aplanar configuration;

FIG. 3D is a further alternative internal component, similar to theinternal component of FIGS. 3A-3B but having longitudinal piping runningalong its exterior and interior surfaces;

FIG. 3E is an end view of the internal component of FIG. 3D;

FIG. 4 is an isometric view of a transfer device (referred to as“T-Device”) for displacing the PSD along the penile shaft duringimplantation;

FIG. 4A is another isometric view of the T-Device of FIG. 4;

FIG. 4B depicts how the T-Device engages the inner component of the PSDthrough the dorsal slit to displace the PSD along the penile shaft;

FIG. 5 is a plan view of an exemplary glans gripper device used forgrasping the penis glans during PSD implantation;

FIG. 5A depicts how the glans gripper device grasps the penis glansfollowing degloving of the penile shaft;

FIG. 6 depicts how penile measurements are taken for an erect penis;

FIG. 6A depicts how penile measurements are taken for a hyperextendedpenis;

FIG. 6B depicts how penile measurements are taken for a flaccid penis;

FIG. 6C depicts how penile measurements are taken for a flaccid deglovedpenis;

FIG. 6D depicts how penile measurements are taken for an erect deglovedpenis;

FIG. 6E depicts how penile measurements are taken for a hyperextendeddegloved penis;

FIG. 7 shows the patient's penis prior to implantation of the PSD andwhere the existing circumcision scar is to be opened;

FIG. 7A depicts how the penis is degloved and the penile skin is pushedproximally toward the pubic area;

FIG. 7B depicts how the glans gripper device is used to deliver the PSDonto the degloved penis after penile measurements have been taken;

FIG. 7C depicts the suture slits of the PSD being exposed to permit penmarkings on the penile shaft to be made therethrough;

FIG. 8 depicts the PSD implanted on the penile shaft, the penile skinreturned to the circumcision line and external sutures being used toclose the circumcision line;

FIG. 8A depicts the additional step of implanted a filler around theimplanted PSD to further increase penile girth;

FIG. 8B depicts a flaccid penis and FIG. 8C is enlarged cross-sectionalview of the flaccid penis taken along line 8C-8C of FIG. 8B;

FIG. 8D is a cross-sectional view similar to FIG. 8C but showing the PSDimplanted on the penile shaft;

FIG. 8E is functional longitudinal cross-sectional view of a penisdepicting the various vessels therein;

FIGS. 8F and 8G are cross-sectionals views of a penis and a penis havingthe PSD implanted therein to demonstrate the increased girth added bythe presence of the PSD;

FIGS. 8H and 8I are side views of a penis and a penis having the PSDimplanted therein to demonstrate the increased penile length added bythe presence of the PSD;

FIG. 8J is a diagrammatic view of a penis with Peyronie's Diseaseshowing how the presence of plaque misshapes the penis;

FIGS. 8K and 8L are cross-sectionals views of a Peyronie's Disease penisand a Peyronie's Disease penis having the PSD implanted therein todemonstrate the increased girth added by the presence of the PSD;

FIG. 8M depicts how the implantation of the PSD restores a more naturalerect profile to a penis with Peyronie's Disease;

FIG. 9 is a functional diagram showing how the dorsal cuts close whilethe ventral cuts open in the internal component (shown in phantom) ofthe PSD when the penis is moved in an upward direction;

FIG. 9A is a functional diagram showing how the dorsal cuts open whilethe ventral cuts close in the internal component (shown in phantom) ofthe PSD when the penis is moved in a downward direction;

FIG. 9B is a cross-sectional view of the PSD taken along a line similarto 1H-1H of FIG. 1A showing the U-shaped ventral portion in a neutralcondition;

FIG. 9C is a cross-sectional view of the PSD similar to FIG. 9B butshowing how the U-shaped ventral portion expands to permit urinary flowin the flaccid and erect states by relieving pressure on the urethra;

FIG. 10 is an isometric view of the PSD-S fold embodiment of the presentinvention;

FIG. 10A is an exploded isometric of the inner component that utilizes asecond semi-cylindrical second inner component thereon;

FIG. 10B is a partial longitudinal cross section showing how theinternal component and the second internal component are positioned inthe pocket of the main component;

FIG. 10C depicts an alternative PSD embodiment referred to as the “PSDCollapsible” whereby fluid is initially stored between the maincomponent's inner and outer layer when the penis is in a flaccid state;

FIG. 10D is a cross-sectional view of the proximal end flange takenalong line 10D-10D of FIG. 10C;

FIG. 10E is a cross-sectional view of the middle portion of the PSDCollapsible taken along line 10D-10D of FIG. 10C;

FIG. 10F depicts the PSD embodiment when the penis becomes erect,thereby pushing the stored fluid into the proximal end flange, causingthe proximal end flange to expand;

FIG. 10G is a cross-sectional view of the proximal end flange takenalong line 10G-10G of FIG. 10F;

FIG. 10H is a cross-sectional view of the middle portion of the PSDCollapsible taken along line 10H-10H of FIG. 10F;

FIG. 10I depicts a further alternative PSD embodiment referred to as the“PSD Volume Shift” whereby an expandable reservoir is coupled to the PSDvia the proximal end flange and which depicts the penis moving from aflaccid state to an erect state, thereby displacing stored fluid fromthe PSD, through the proximal end flange and into the reservoir;

FIG. 10J is a functional diagram of the PSD Volume Shift embodimentshowing how fluid moves from the PSD through the proximal end flange andinto the reservoir;

FIG. 10K is a cross-sectional view of the reservoir taken along line10K-10K of FIG. 10J;

FIG. 10L is a cross-sectional view of the middle portion of the PSDVolume Shift taken along line 10L-10L of FIG. 10J;

FIG. 10M is a functional diagram of the PSD Volume Shift embodimentshowing the condition of the PSD Volume Shift when the penis is fullyerect;

FIG. 10N is a cross-sectional view of the reservoir taken along line10N-10N of FIG. 10M;

FIG. 10O is a cross-sectional view of the middle portion of the PSDVolume Shift taken along line 10O-10O of FIG. 10M;

FIG. 10P is a side view of an even further alternative PSD embodimentreferred to as the “PSD Spoke” whereby collapsible spokes between theinner layer and the outer layer of the main component are present toaccommodate the change of penis state from flaccid to erect or viceversa;

FIG. 10Q is a cross-sectional view of the PSD Spoke of FIG. 10P takenalong line 10Q-10Q of FIG. 10P when the penis is in the flaccid state;

FIG. 10R is a cross-sectional view of the PSD Spoke of FIG. 10P akenalong line 10Q-10Q of FIG. 10P when the penis is in the erect state,showing the spokes in a collapsed state;

FIG. 10S is a side exploded view of another alternative PSD embodimentreferred to as the “PSD Insert” whereby the main component of the PSDhas discrete members that are coupled together using tongue and grooveconnections;

FIG. 10T is a cross-sectional view of the PSD Insert taken along line10T-10T of FIG. 10S;

FIG. 10U is a cross-sectional view of the PSD Insert taken along line10U-10U of FIG. 10S;

FIG. 10V is a cross-sectional view of the PSD Insert taken along line10V-10V of FIG. 10S;

FIG. 10W is an isometric view of another PSD embodiment referred to asthe “PSD Telescope” wherein the main component comprises two distinctportions that can slide over the internal component;

FIG. 10X is an isometric view of the PSD Telescope shown with the twodistinct portions displaced away from each other, exposing the internalcomponent;

FIG. 10Y is a cross-sectional view of the PSD Telescope taken along line10Y-10Y of FIG. 10W;

FIG. 10Z is a cross-sectional view of the PSD Insert taken along line10Z-10Zof FIG. 10X;

FIG. 11 is an isometric view of a penile stocking insert of the presentinvention

FIG. 11A is a side view of the penile stocking insert showing a verticaledge on the right end;

FIG. 11B is a side view of the penile stocking insert showing a diagonaledge on the right end;

FIGS. 11C and 11D show side views of a penis with the respective penilestocking insert implanted therein;

FIG. 11E is a cross-sectional view of the penile stocking insertimplanted on the penile shaft;

FIGS. 11F and 11G show respective views of the penile stocking insertimplanted within the penile stocking insert of FIG. 11G being longerthan the penile stocking insert of FIG. 11H; and

FIG. 11H shows a prior art penile implant from U.S. Pat. No. 6,537,204(Elist).

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the figures, wherein like reference numerals representlike parts throughout the several views, exemplary embodiments of thepresent disclosure will be described in detail. Throughout thisdescription, various components may be identified having specificvalues, these values are provided as exemplary embodiments and shouldnot be limiting of various concepts of the present invention as manycomparable sizes and/or values may be implemented.

Any feature or combination of features described herein are includedwithin the scope of the present invention provided that the featuresincluded in any such combination are not mutually inconsistent as willbe apparent from the context, this Specification, and the knowledge ofone of ordinary skill in the art. Additional advantages and aspects ofthe present invention are apparent in the following detailed descriptionand claims.

As used herein, the term “proximal” refers to being situated near ortowards the pubic area. The term “distal” refers to being situated awayfrom the pubic area. The term “ventral” refers to the underside of thepenile shaft. The term “dorsal” refers to the top side of the penileshaft. The term “medial” refers to the midline longitudinal area of thepenile shaft. The term “lateral” refers to the right or left side of thepenile shaft. The term “glans” refers to the ‘head’ of the penis. Theterm “glans corona” or “glans rim” or “coronal rim” refers to the baseof the glans at its widest location. The term “penile shaft” refers tothe tubular portion of the penis excluding the glans. The term “urethra”refers to the urinary tubular structure found on the ventral side of thepenile shaft. The term “scrotum” refers to the skin that covers thetesticles. The terms “epidermis” and “dermis” refer to the two primarylayers of skin which is common to all skin, including the penile skin;the epidermis being the very top layer, and the dermis being theimmediate layer below the epidermis. The term “glans meatus” is the‘hole’ in the glans from which urine exits from. The term “fascia”refers to circular or tubular shaped tissue that forms the penile shaftstructure, and this fascia is found immediately under the penile skin.There are three layers of this fascia; the first and most superficial isthe “dartos fascia” which lies immediately under the penile skin; thenthe next layer of fascia is called “Buck's Fascia” which lies below thedartos fascia; and the final and deepest fascial layer is called the“tunica albuginea”. All of these fascial layers form a tubular shapewhich forms the main structure of the penis itself. Where there is anerection, blood flows within the tunica albuginea, specifically into thespace within this fascial layer called the corpora cavernosa and corporaspongiosum, and ‘fills it up’ and expands it like filling a tubularballoon with air. The term “buckle” refers to the ability to collapse orcompress. The term “suture” refers to the string like material used forstitching up skin, etc. The term “gradually” or “tapering” is defined asrising or descending at an even, moderate inclination. The term“smoothly” is defined as having an even surface or edge free fromirregularities, sharpness (i.e., hard-angled corners), or roughness.

As will be discussed in detail below, a penile sleeve device (PSD) isconfigured for implantation in the subcutaneous space of a patient'spenis and is designed to enhance and/or correct penis shape and size,treat low to moderate level erectile dysfunction, and correct peniscurvature and malformation. Several different embodiments of the penilesleeve device are disclosed herein:

Penile Sleeve Device Sample FIG. Reference Number PSD-smooth FIG. 2I 20PSD-S-fold FIG. 2K 20A PSD-wavy-fold FIG. 2J 20A1 PSD-Tight-S FIG. 2L20A2 PSD-Collapsible FIG. 10F 20B PSD-Volume Shift FIG. 10I 20CPSD-Spoke FIG. 10Q 20D PSD-Insert FIG. 10S 20E PSD-Telescoping DesignFIG. 10X 20F PSD-Fused FIG. 2G 20 PSD-12 Inch FIG. 10 20AThe PSD-smooth 20 referred to simply as “PSD 20” will be discussedinitially to explain the overall penile sleeve device construction anduse. The designator “PSD-smooth” 20 refers to the outer and inner layersof the main component 22 (to be discussed in detail later) whichcomprise “smooth layers.” However, it should be understood that thepreferred embodiment of the penile sleeve device is the PSD-S-fold 20Aand its variations, PSD-wavy-fold 20A1, and PSD-Tight-S 20A2.

PSD 20: General Structure and Shape

The penile sleeve device (PSD) 20 is an implantable sub-cutaneous penileshaft silicone rubber device. The PSD 20 comprises a plurality of parts.The PSD 20 has multiple potential functions. The first, or primaryfunction, is to elongate the penile shaft PS in the flaccid or/and erectstates whereby depict a normal penis P in a flaccid state (FIG. 8H) ascompared to a penis having the PSD 20 implanted therein (FIG. 8I). Asecondary function is to increase the girth of the penile shaft in theflaccid and erect states whereby (FIG. 8F) depicts a normal penis girthas compared to a penis having a PSD 20 implanted in a penis and formedto enhance penile girth EPG (FIG. 8G). A third function is to harden orincrease firmness of the penis, allowing for a harder or firmererection, which assists in patients with mild or moderate forms oferectile dysfunction. A fourth function is to straighten a curved penis.For example, a penis may have a natural curvature or may have acurvature due to a pathological state, such as is seen in Peyronie'sDisease, which is shown in FIG. 8J. In particular, internal plaque (PLQ)causes the penis with Peyronie's Disease PPD to misshape as shown inFIG. 8J. By implanting the PSD 20 of the present invention, the curvedpenile profile can be partially or fully corrected (FIG. 8M), while alsoincreasing penile girth (FIGS. 8K-8L). The fifth function is to customshape the penis. A patient may want a much thicker proximal base area,or some built in “bumps” 22G, or a large veiny look 22F, etc.

As mentioned above, the PSD 20 has multiple functions, such as toelongate, thicken, harden, straighten, and custom shape the penis. Anyone of, or a combination of, these functions can be achieved with thePSD according to the patient's desires. These functions may be achievedusing multiple PSD structural forms, with only minor alterations. Toachieve these variations a two-part PSD design, is used in most, if notall, applications. There will be additional minor parts to the PSD,however, there will be two major parts, the main component and theinternal component, to be discussed later. The other design variationsinclude: the PSD-Smooth 20, PSD Wavy-Fold 20A1, PSD Tight-S 20A2, PSD:Collapsible 20B, PSD Volume Shift 20C, PSD: Spoke 20F, PSD: Insert 20E,PSD: Telescoping Designs 20F, PSD: Fused, and PSD: 12-inch. Thesealternate design variations will fulfill the same objectives as the PSD.As will be discussed below, the PSD comprises a two-part design.Variations in size, shape, length, and thickness of each part assists inaccommodating for most if not every flaccid and erect clinical scenarioencountered.

PSD: General Structure

The PSD comprises two main parts (FIG. 2G), an outer tubular section orMain Component (MC) 22 and an inner partial tubular section or InternalComponent (IC) 24 such that when they are coupled together, theyeffectively form a ‘tri-layer tube’ on the dorsal lateral sides, and a‘bi-layer’ tube on its ventral side. This can be seen most clearly inFIG. 1H. The Main Component (MC) 22 (FIGS. 1L-1Q) is an elongated membercomprising a distal end 22A, a medial ventral area 22B, a medial dorsalarea 22C, and a proximal end flange 22E. The Internal Component 24(FIGS. 3-3B) is an elongated member comprising a distal end 24A, a bodyportion 24B, proximal end of the Internal Component proper 24C, and aproximal end flange 24D. The proximal end flange 24D of the InternalComponent 24 and the proximal end flange 22E of the Main Component 22,when both flanges are put together to make the completed PSD 20. Thiscombined “flange” areas of the Internal Component 24 and Main Component22 is called the Proximal Double Flange End (FIG. 2A). The InternalComponent 24 has a C-shape (e.g., FIGS. 3A-3E), being open along a“ventral” (under) side, as opposed to its closed dorsal (top) side. TheMain Component 22 is the component that is in direct contract withpenile tissues. The Internal Component 24 is not in direct contact withany penile tissues but is located within the Main Component 22, as willbe described in detail later. Both components 22/24 are used in mostapplications of the PSD 20 to meet the patient's needs and desires.

PSD: Main Component 22

The Main Component 22 comprises a moderate to high flexible and stretchysilicone rubber elastomer. One of the main functions of the MainComponent 22, which is in direct contact with the penile tissues, is towork in combination with the Internal Component 24 (which is not indirect contact with the penile tissues) and provide a soft, safe, andnon-irritating interface between the PSD 20 and the penile tissues.Other functions of the Main Component 22 aid in keeping the penisoutstretched in the flaccid or erect states and provides additionalgirth, if desired, as well. The Main Component 22 provides low tomoderate firmness, and plays a moderate role in structural support,curvature corrections, and adding additional “hardness” for erectiledysfunction issues. The Main Component 22 provides that criticalnon-irritating interface between the PSD 20, as a whole, and the peniletissues (shielding the harder Internal Component 24 from the peniletissues and thereby eliminating potential penile tissue irritation). TheMain Component 22 is simply too flexible in nature to fully assist inthe structural support functions, and that is why a harder, more firmpart, the Internal Component 24, is needed. The Main

Component 22 can be molded into a variety of shapes such as adding aveiny look 22F, or adding some “bumps” 22G, etc., as shown in FIG. 1.

The Main Component 22 has several functions. Its primary function it tostabilize the out-stretched penile shaft maintaining an extended flaccidand/or erect length. It helps prevent the penile recoil forces fromretracting to a smaller flaccid or erect state. The mechanism by whichthe Main Component 22 extends the penile shaft is two-fold. The MainComponent 22 provides inwardly-directed radial force F_(RI) directly onthe penile fascia, gripping and holding it “in place” in anout-stretched position. Secondly, the Main Component 22, which abuts thepubic boney area proximally and is mounted in place distally withsutures, acts to physically hold the out stretched penis in position,like a splint. This mechanism allows the penile fascia and penile shaftto remain out-stretched during the flaccid and erect states.

The Main Component 22 is designed with soft silicone material tointerface with the penile tissues. This material aspect of the device iscritical in providing the least amount or the total elimination oftissue irritation and thus greater patient comfort for long term use.Using this type of material as an interface, with the additional designfeatures such as soft rounded edges, balanced non-excessiveinwardly-directed radial forces F_(RI) exerted, and great flexibilitylowering tissue tension upon penile bending and stretching, providessound medical design safety features for patient comfort and long-termuse.

Additional alterations to the Main Component 22 include thickening toprovide additional girth, hardening to provide additional firmness andstraightening, and custom molding to provide veins 22F, bumps 22G, orasymmetrical penile shaft shapes can be made as needed.

The anatomic location or placement of the Main Component 22 is in thesubcutaneous space of the penile shaft, and in direct contact with thepenile tissues. The PSD 20, specifically the Main Component portion 22,lies directly on top of Buck's and Tunica Albuginea Fascia and touchesthe subcutaneous (viz., undersurface of the) skin.

The Main Component 22 is in contact with the tissues, so medical safetyconsiderations are needed such as the device being soft/semi-soft indurometer, very stretchable and elastic (to allow for the erectionexpansion process and low tension upon penile bending, pulling, etc.),smooth, rounded in all areas to prevent tissue trauma or irritation, andhaving an acceptable safe long-term biomaterial. The material of choice,medical grade silicone, which can be manufactured as a very stretchableand elastic product, allows for unimpeded blood flow into the penileshaft during the erection process due to its elastic characteristics.This material also elicits the foreign body reaction and results in acollagen envelope which will surround the entire PSD 20 over a shortperiod of time. This is advantageous because it promotes stability,providing a tethering down of the PSD 20, but also provides a protective“cocoon” and prevents the immune system from trying to chemically breakdown the PSD 20.

The MC 22 will have some assistance in expanding by theoutwardly-directed radial force of the Internal Component (IC) 24 (asdiscussed below).

The MC 22 is formed from a single mold. The IC 24 is formed from asingle mold.

The MC 22 thickness varies from 1-20 mm, but is relatively high in mostcases, as compared to the IC 24 thickness (ranging from 1-10 mm).

Both the MC 22 and the IC 24 are manufactured in specific lengths. MC 22sizes range from 3 inches (measuring the length of the erect penis onthe ventral side), with 0.5-inch incremental increases up to 12 inchesin length. IC 24 sizes range from 2.0 to 11.5 inches with 0.5-inchincremental sizes.

The MC 22, in most cases, is designed to be used with the IC 24. Thereason for this combination of components is to assist the more“fragile/soft” MC 22 with structural support provided by the IC 24. Thisadditional structural support by the IC 24 helps prevent the MC 22 frombuckling, bending, and bowing, and, in addition, provides firmness(“erection firmness”), and prevents unwanted folding upon itself (e.g.,like forming a shirt sleeve cuff) at the proximal or distal ends.

As shown most clearly in FIG. 1H, the MC 22 is a combination bilayer 22Sand single layer 22W. The MC 22 on its dorsal (top side) and lateralsides is a bilayer 22S. The MC 22 on its ventral side (bottom side) is asingle layer 22W. The MC 22 on its very distal and very proximal areasare a single layer 22W. The bilayer area 22S is composed of an innerlayer 22S1 and an outer layer 22T1. This bilayer forms a space or“pocket space” 22I (FIG. 2G) between the inner layer 22S1 and the outerlayer 22T1. This pocket space 22I is designed to house the IC 24 asshown in FIGS. 1H and 2G. This pocket space 22I extends within the MainComponent to certain points distally, proximally, dorsally, andventrally.

The MC 22 comprises the pocket space 22I which extends within the MCbilayer 22S a certain distance from dorsal to ventral, and distal toproximal, as shown in FIG. 2G. The IC 24 is placed within this pocketspace 22I through a slit like opening of the MC 22 called the dorsalmid-line slit (22J). The pocket space 22I has near identical dimensionsas the IC 24, because the union of these two elements, the pocket space22I and IC 24, are to fit like a ‘hand in a glove’, the handrepresenting the IC 24, and the glove, representing the pocket space ofthe MC 22. These two components, 22/24, once positioned, are heldtogether in place (FIG. 2G); In addition, the pocket space 22I of the MC22 extends into the MC 22 proximal end flange 22E. This portion of thepocket space 22I that is in the MC proximal end flange 22E accommodatesfor the Internal Component proximal end flange 24D. When the IC 24 ispositioned within the MC pocket space 22I, the two units, now formingthe PSD 20 in total, will be stable and act as “one” unit functionally.

The IC 24, once placed within the pocket space 22I of the MC 22, willexert a mild outwardly-directed radial force (F_(RO), see FIG. 1I) onthe MC 22. This outwardly-directed radial force F_(RO) will counteractthe inwardly-directed radial force (F_(RI), see FIG. 1I) exerted by theMC 22. The MC 22, with its pocket space 22I, resists and stabilizes theIC 24's potential outwardly-directed radial force F_(RO), therebypreventing the IC 24 from expanding unopposed. This feature of the IC 24exerting an outwardly-directed radial force, F_(RO), (see FIG. 1I),helps the PSD 20, in total, with regard to minimizing the overallinwardly-directed radial fore F_(RI) onto the penile tissue and therebydoes not impede the blood flow into the penile tissues during theerection process. In other words, the outwardly-directed radial forceF_(RO) exerted by the IC 24 reduces on the MC 22's inwardly-directedradial fore F_(RI) (see FIG. 1I) and takes the stress off the erectioninward blood flow pressure process.

Even though the MC 22 is made of soft, flexible, compressible, andexpandable material, a “buckle space” 22L is designed in to allowadditional “slack” and “compression”, if needed, during penile bending,pulling, etc.

Even though the MC 22 is, in most instances, used in conjunction withthe IC 24, there may be certain circumstances where the flaccidretraction force is minimal and use of only the MC 22, without the needfor extra structural support from the IC 24, may provide the clinicalresults desired.

As mentioned previously, the MC 22 outer layer 22T1 may also be texturedto provide a desirable look and feel. For example, patients may want a“veiny” look 22F (FIG. 1) to the penile skin surface. This veiny look22F can be accomplished by adding such a texture profile to the molddesign. Alternatively, or in addition, the MC 22 can be supplemented tohave “bumps” 22G (see FIG. 1). On the other hand, where a permanentfiller is used (viz., around the outside of the implanted PSD 20) tothicken the penile skin (e.g., to increase girth), the veiny texture 22Fand/or bumpy texture 22G might be obscured.

Suture anchor locations 22M (FIG. 5A) on the penile tissue will bedetermined by using a marker pen. The PSD 20 will be placed intoposition, the penile shaft will be artificially erected, and the markerpen will be placed through suture anchor slits 22N (in the inner layer22S1 of the MC 22, FIGS. 2B-2C) and 24G (of the IC 24, FIG. 3) of thePSD 20 to mark the suture anchor locations 22M locations on the peniletissue. On occasion, additional suture anchor areas will be needed tosecure the PSD 20, and, in particular, when penile retraction forces arevery high, especially in the case of moderate penile length shorteningthe flaccid state, and PSD 20 placement for lengthening during thenon-erect state. Considering this, multiple or additional mountinglocations on the proximal and mid-shaft regions of the penile shaft maybe necessary to divert excessive force which may be transmitted to theGlans Coronal area from the recoiling of the penile shaft and causing adistal shifting of the PSD 20 onto that area. Optional distal,mid-shaft, and proximal, suture anchor slits 22NA (in the inner layer22S1 of the MC 22) and 24GA (in the IC 24, FIG. 3) in the PSD 20 will beavailable, if additional support is needed.

As mentioned previously, the MC 22 comprises a pocket space 22Iextending from dorsal to lateral sides, and proximal to distal sides,including into the proximal end flange of the MC 22. This pocket space22I houses the IC 24. This “hand-in-a-glove” fit between the MC pocketspace 22I and the IC 24 prevent or limit movement of the IC 24 withinthe pocket space 22I of the MC 22.

During movement of the penile shaft, whether it be from sexualintercourse, or movement within underwear, etc., the PSD 20's twocomponents 22/24 will slide on one another internally. For example, asmost clearly in FIGS. 3 and 9, during dorsal or upward bending motions,the IC 24 comprises a plurality of dorsal V-cuts 24H having edges 24HEthat will approximate and close the V-cuts 24H. Similarly, as mostclearly in FIGS. 3 and 9A, during ventral or downward bending motions,the IC 24 also comprises a plurality of ventral V-cuts 24I having edges24IE that will approximate and close the V-cuts 24I. For either ofapproximation to occur, the V-cut edges 24HE need to move closertogether and therefore “slide” against the inner surface 22T2 (FIG. 1H)of the MC 22's outer layer 22T1 as well against the outer surface 22S3of the MC 22's inner layer 22S1 (FIG. 1H). This “‘sliding” of the IC 24within the pocket space 22I may cause friction and thus wear and tear ofthe surface material. As shown most clearly in FIG. 2A, to eliminate thepotential wear and tear of the IC 24 rubbing against the internalsurfaces of the inner 22S1 and outer 22T1 layers of the MC 22 duringpenile bending motions, a layer of lubrication L-Lube (e.g., siliconeoil) may be positioned within the pocket space 22I of the MC 22 whichwill allow for easy sliding and much less friction of the IC 24 withinthe MC 22.

The proximal lateral areas, bilaterally, of the MC 22, further comprisesa proximal lateral V-cut 22O (e.g., FIGS. 1N and 1O), the purpose ofthis V-cut 22O is to allow for the proximal ventral portion of the PSD20 to bend when the penile shaft is bending in a ventral direction. TheV-cut 220 will provide “give” or move in a ventral direction decreasingthe force of the PSD 20 proximal ventral area from pressing on ventralpenile anatomic structures, such as the urethra, thus eliminating directforce and potential irritation of the penile tissues.

The distal end 22A of the MC 22 comprises a tapered end 22P to provide acomfortable interface against the glans when placed, and for a subtlecosmetic tapering or narrowing as the PSD 20 approaches the sub-glansarea.

PSD: Internal Component 24

The IC 24 comprises a much higher durometer silicone rubber materialwith the possible addition of a plastic and/or malleable metal alloy.Depending on the amount of hardness needed, high in the case of treatinglow to moderate levels of erectile dysfunction (ED) and moderate to highlevels for erect lengthening needs, the IC 24 can be made of many typesof materials and combinations of materials. The type of materialsinclude but are not limited to metal malleable alloys, plastic or resinmaterials, silicone rubber materials with varying durometers, or anycombination thereof. The IC 24 is the portion of the PSD 20 thatprovides the main structural support in keeping the penis outstretchedin the flaccid and erect states, helps correct penile curvatures, andassists in providing additional hardness in ED issues. The IC 24, by itssimple volume, provides some girth. The IC 24 plays a significant rolein treating erectile dysfunction, considering it can provide hardnessand the ability to be bent upwards (erect state) and then bend downwards(for the flaccid state) via the malleable alloy component. An additionalinternal component 24J (FIG. 10A) can be added to provide additionalsupport in cases of moderate curvatures.

The IC 24 has several functions. Considering the potentially highretraction forces involved with an out-stretched non-erect flaccidand/or erect penis, the IC 24 provides the necessary structural supportfor preventing penile retraction and for preserving the MC 22 shape andintegrity. The IC 24 also prevents the more fragile flexible/stretchy MC22 from folding on itself (e.g., such as a shirt sleeve rolling up orfolding upon itself, especially at the distal end), prevent buckling,and prevent bowing outwards (like an accordion effect).

The anatomic location of the IC 24 is directly within the bilayer space,or pocket space 22I of the MC 22. Since the IC 24 is partially tubular,with a C-shape, it does not extend to the ventral surface of the MC 22.The IC 24 is not in direct contact with any penile tissues. The MC 22comprises a dorsal mid-line slit 22J, acting as the “doorway entrancepoint” to allow the IC 24 to be placed into the pocket space 22I; onceinserted, the IC 24 is no longer visible after the dorsal mid-line slit22J is reapproximated and closed. As is seen most clearly in FIGS. 2-2A,the dorsal mid-line slit 22J closes with a special tongue 22JT andgroove 22JG closure to “seal” this slit shut; this includes preventingliquids or lubrication (e.g., L-Lube mentioned previously) from exitingthrough the slit 22J. Both the MC 22 and the IC 24, when joined togetheras one unit, are placed in the subcutaneous space of the penile shaft,on top of Buck's and Tunica Albuginea Fascia and under the penile skin(see FIG. 8D, for example).

The IC 24 provides the MC 22, as well as the two-part unit as a whole(PSD 20), with a hardening or firming effect during the flaccid anderect states, since the durometer (or hardness) of the IC 24 is muchhigher. The IC 24 has mild to moderate stretch-ability. The IC 24 alsohelps counter penile curvature forces and assists in the straighteningof the penile shaft. The IC 24 will provide some thickening of thepenile girth as well, if needed.

As in the MC 22, the IC 24 also includes a proximal lateral V-cut 24E(FIG. 3) which aligns with proximal lateral V-cut 220 of the MC 22 whenthe tubular sections are coupled together. Similarly, the IC 24 alsocomprises a buckle zone 24F (FIG. 3) that aligns with the buckle zone22L of the MC 22 when the two components are assembled. Moreover, the IC24 further comprises suture slits 24G near the distal end 24A that alsoalign with the suture slits 22N of the MC 22 when the two components areassembled. Additional suture slits 22NA/24GA may be located at themid-shaft and proximal areas of the PSD 20.

As can be most clearly seen in FIG. 3, the dorsal side of the IC 24 maycomprise a plurality of dorsal V-cuts 24H. The purpose of the pluralityof dorsal V-cuts 24H is to permit dorsal bending of the PSD 20 such thatthe IC 24 can “collapse” (and not lengthen with dorsal bending) withoutrequiring the proximal end flange 24D to displace any further within theMC 22's proximal end flange pocket 22Q (FIG. 2G), and thereby place ortransmit excessive pressure on the bony and ligamentous structures inthe pubic space/pocket (see FIG. 8E). The ventral side of the IC 24 maycomprise a plurality of ventral V-cuts 24I. The purpose of the pluralityof ventral V-cuts 24I is to permit ventral bending of the PSD 20 suchthat the IC 24 can “collapse” and limit its proximal lengthening ormovement and thus limit or eliminate any pressure exerted by the IC 24end flange 24D, and to prevent the ventral portion of the PSD 20 to movein a ventral or ventral-proximal direction.

The IC 24 will also have optional “piping” 24N (FIGS. 3D-3E) on theinner and/or outer surfaces thereof. The piping will be made of the samesilicone material and durometer as is the IC. The piping 24N will beelevations, about 1mm high and rounded, and run the course,longitudinally, to the IC 24's proximal to distal end. This piping 24Nwill be separated by 4-10 mm apart. The inner surface and outer surfacepiping 24N will be “staggered” and not be aligned or place “on top” ofeach other (see FIG. 3E). This piping 24N will provide structuralsupport for the IC 24 and provide less surface area for the IC 24 tointeract with the MC 22. Less interaction will limit wear and tear asthese two components slide and rub on one another. This piping 24Ndesign may eliminate the need for lubrication as well. It should beunderstood that the dorsal V-cuts 24H, ventral V-cuts 24I and the bucklezone 24F are omitted in FIG. 3E for clarity only but could also beincluded therein.

The MC 22, IC 24, and associated minor components such as the sutures S,suture clips 80, T-Device 30 (all of which will be discussed below),etc., work together to provide for delivery of the PSD 20 and for PSD 20functionality. In addition, these components are designed not only forcertain functions, such as flaccid and erect lengthening, girthenlargement, curvature correction, erectile dysfunction ‘hardening’assistance, and different custom cosmetic designs and shapes, as desiredby the patient, but also designed for medical safety which includes thevery materials used as well.

The MC 22 and IC 24 are manufactured in specific predetermined lengths,diameters, and special features. Specific lengths and internal diametersizes are clinically superior, or advantageous, such as havingincremental sizes with lengths ranging from 3.5 inches, with 0.5-inchincremental increases up to about 12 inches in length. It should benoted that the IC 24 is approximately 1 to 2 inches shorter than the MC22 length. Additional manufacturing variables include various internaldiameter sizes to fit patients with low to high penile shaft girthsizes, multiple durometers and girth sizes, multiple material types, andcustom options as well. As mentioned previously, the IC 24 is shapedlike a tube but is an incomplete tube, being open on its ventral side, aC-shaped tubular structure (see FIGS. 3A-3B). This opening of the “C”shaped tubular structure not only allows for expansion during anerection, but does not place pressure on the urethra, directly orindirectly, which is anatomically located on the ventral mid-line areaof the penile shaft. This C-shaped configuration is also referred to as“open tubular section.” In addition, the IC 24 is manufactured with alarger diameter opening, or even as a flat sheet (FIG. 3C), unlike thetubular shape of the MC 22. As discussed earlier, the IC 24 fits intothe pocket space 22I of the MC 22; however, the IC 24 will need to becompletely folded/rounded, in the case of a flat-manufactured sheet 24′(FIG. 3C), or partially squeezed closed (FIG. 3B), in the case of acircular-manufactured form, to get it to align and fit into the MCpocket space 22I. As such, the IC 24 is designed to be elasticallydeformable, and once elastically formed into the desired shape, it willprovide outwardly-directed radial force F_(RO) once placed into the MCpocket space 22I. Thus, the IC 24 is always expanding outward, due to itbeing folded, and this outwardly-directed radial force F_(RO) assists inthe outward expansion of the PSD 20 during an erection.

There are many differences between the IC 24 and prior art penileimplants. In particular, these prior art penile implants comprise asingle part device, providing both penile length and/or girth, having arelatively high durometer, or hard, and this hard device is in directcontact with the penile tissues. The direct contact with penile tissuesdoes, in most cases, results in undesirable pressure points. These typesof penile implants transmit stress, through these pressure points,directly to the penis glans, sub-glans tissues, penile shaft fascialtissues, and pubic ligament and bony tissues, which may result intenderness and pain (considering the penile recoil forces on thedevice). Chronic exposure of the penile tissues to these pressure pointscan cause skin inflammation and even result in the necrosis of the skinand rupture of the device through the skin. In contrast, the highdurometer IC 24 is not in direct contact with the glans, sub-glans orany penile tissues, but rather only the very soft low durometer MC 22;and it is only the much softer MC 22 that is in direct contact withpenile tissues. The IC 24 provides certain functions such as hardness,counters the penile retraction forces, supports the MC 22, and providessome girth, while the MC 22 provides a safe cushion interface betweenthe IC 24 and with the penile tissues, and also provides counter penileretraction forces and girth. This combination of parts provides fortissue comfort, an acceptable external cosmetic “feel” when in theflaccid and erect states, and minimizes or eliminates tissue irritation,tenderness, pain, and possible skin rupture.

In addition, the MC 22 and the IC 24 are designed to alter shape withpenile bending. While the penis bends, the device is designed to “bendwith” the penis preventing device pressure points on the penile tissuesand skin. In contrast, some prior art penile implants are made ofrelatively hard materials and are not only not able to bend freely, butnearly prevent the natural bending, in any direction, of the penis inthe flaccid or erect states. Considering the non-flexibility of theseother devices, any bending of the penile shaft causes the hard device to“dig into” the penile tissues. This digging into the penile tissues, orcausing pressure points, is due to the non-bending of this hard-rigidstructure causing direct high pressure on the penile tissues and skin.This inability to not shorten during bending motions simultaneously withthe penile shaft bending (which will collapse and shorten when bent),will result in proximal and distal excessive pinpoint pressures onpenile tissues, especially near the glans, penile skin, and at glans andpubic pocket areas. This excessive pinpoint pressure may result inirritation and possible tissue necrosis (tissue death). The samepressure points will be observed with any penile bending or even an upor downward motion experienced during intercourse. This rigid,non-bending type of device placed into the penile tissues and skin hasthe potential for major issues, such as being a major source ofirritation, inflammation, pain, and skin erosion with the potential forthe device to break through, literally through, the skin.

In contrast, the IC 24 is not in direct contact with the tissues, whichis a key medical safety design.

The IC 24 position allows for a much higher durometer (hardness) to beused since the IC 24 is in direct contact with only the softer MC 22only, and not the penile tissues directly, especially at the proximaland distal ends where most of the stress is applied from the retractionforces.

The IC 24 is formed from a single mold.

The IC 24 is made from a medium to high durometer silicone elastomer,with the potential of additional elements such as plastic, resins,and/or malleable metals.

The IC 24 does not provide significant girth or penile shaft thickness,but in certain circumstances it can, if needed.

The IC 24 can fold upon itself, but not easily, like the MC 22, due toits higher durometer.

As described previously, the IC 24 is designed to be used with the MC22. The IC 24 cannot be used independently because such a use wouldcause the same potential issues as described previously with regard toprior art penile implants, such as pressure sores, pain, skinulceration, and penetration of the device through the skin.

The IC 24 may not be needed in certain circumstances, such as in thecase where the flaccid retraction force is minimal and a MC 22 onlytreatment may be appropriate.

The IC 24 comprises multiple suture slit locations 24G/24GA as does theMC 22, since the anchor slits 22M, and subsequent sutures placement,need to go through both components. The reason for additional sutureslit locations is because of the possibility that the retraction forcesare very high, especially in the case of optimal erect lengthening.Considering this potential high force generation by the retraction ofthe penile tissues, multiple suture anchor locations may be necessary tonot only divert excessive force directly onto the glans corona/rim andother areas of the penile shaft if needed, but also to prevent excessiveforce onto any one particular suture mount and thus onto the penilefascial tissues such as the Tunica Albuginea. Since the IC 24 and the MC22 fit together and act as one functional unit, the suture slits 22N/24Galign and the suture S passes through either the MC 22 or both the MC 22and the IC 24 devices at the same time to mount, as needed. There areareas of non-overlap between the MC 22 and the IC 24. For example, theC-Shaped IC 24 will fit into the pocket space 22I of the MC 22, however,the IC 24 will not extend all the way around the penile shaft like theMC 22, so the ventral surface of the PSD 20 will only consist of the MC22. The anchor locations are primarily located where there is overlap,as well as where there will be no overlap. The MC 22 extends slightlybeyond the length of the IC 24 on its distal and proximal locations. Thevery distal end of the IC 24, and the distal end area of the 22, wherethere is overlap, form the suture anchor spaces. Suture anchors haveseveral functions; they can be used to stabilize the IC 24 to the MC 22.Suture anchors can be used to anchor the MC 22 to the penile fascia.Suture anchors can be used to anchor the MC 22 and the IC 24 to thepenile fascia. If the IC 24 and Main Component are mounted to the penilefascia, anchor suture slits will align so the suture can loop aroundboth MC 22 and the IC 24 and attach to the penile fascia (see FIG. 2E,for example).

After the appropriate penile length measurements have been taken and theappropriate size PSD 20 selected, the PSD 20 will be placed onto thepenile shaft. Once placed into position, an artificial erection will beinduced, a distal lateral line slit 22Z will be opened to expose thesuture slit, and a tissue marker will be used to place through thesuture slits 22NI/24G of the PSD and make pen marks on the penilefascia. These marks on the penile fascia will assist the Surgeon as towhere to place the sutures. Next, the distal lateral line slit 22Z willbe closed, then the distal end of the PSD 20 will be inverted or foldedto expose the pen marks on the distal end of the penile fascia tissue.Then the sutures S will be placed into Buck's Fascia and TunicaAlbuginea fascia, then the suture threads S, will be placed through thePSD 20 suture slits 22N/24G of the both components of the PSD 20, the MC22 and IC 24. Now, when the sutures S are “threaded” through the PSD 20suture slits 22N/24G, and through the distal lateral line slit 22Z, thenthe distal folded end of the PSD 20 will be unfolded, the suture threadsS pulled completely through. Then the distal lateral line slit 22Z willbe opened, again, to expose the suture slits, and then the suture knotscan be made to secure the PSD 20 into position, then the distal lateralline slit 22Z will be closed to which will cover the suture knots. Asshown most clearly in FIG. 2E, it should be noted that there distallateral line slit 22Z also comprises a tongue 22ZT and groove 22ZG typedesign to form a closure that also prevents fluid movement (e.g.,L-lube) from exiting from the pocket space 22I of the MC 22. It shouldbe noted that at each end of the distal lateral line slit 22J is a tearreduction aperture 22H to minimize any possible tearing of the adjacentMC outer layer 22T1 during opening of the slit 22Z.

In cases where the PSD 20 is providing mild to moderate levels of EDfunctional support, the IC 24 may comprise a malleable metal material.This not only provides for additional firmness, but also allows forsemi-permanent upward (erect position) and downward (flaccid position)bending, as needed, for the appropriate or optimal positioning duringintercourse, and post intercourse. This follows the similar principle asthe metal rod implants (which are placed in the cavernosal chambersdirectly), which are currently being used for moderate ED treatment. Forexample, when the patient wants to have intercourse, he simply bends hispenis in an upward position, and the malleable metal will bend and stayin an ‘erect’ position, and then the patient can have intercourse. Then,when the patient wants to maintain a flaccid state, he bends andpositions the penis downward. The PSD 20, in particular the IC 24, willhave the similar properties, but the PSD 20, in comparison to the metalrod implants for ED, will have far ranging capability to also add penilegirth, penile length, and other features as well.

PSD: Secondary Internal Component 24J

As shown in FIG. 10A a Secondary Internal Component (SIC) 24J for thePSD 20 may be needed in cases where there is a penile curvature that isextreme and additional structural support is warranted. The SIC 24J willbe similar to the IC 24 in shape and material, but will be shorter inlength to accommodate and provide the added support for the penilecurvature area/zone only.

PSD: SIC and IC Plastic/Resin/Metal Component

The IC 24 and the SIC 24J may have the need to be made firmer or harder.There are numerous materials that can provide for the additionalhardness including a very high silicone type material. However, ifother, even harder materials are needed for support, then plastic,resins, or even metal material will be considered. The addition of anyor all of these materials can be done in several ways; for example,small round/square (etc.) flat pieces of metal can be inserted withinthe IC 24 silicone base material to add additional hardness. Anyadditional material, that is harder than the silicone used for the IC24, can be “inserted” within the silicone element of the IC 24.

PSD-Collapsible 20B

An alternative to the PSD-smooth 20 and PSD-S-Fold (20A, 20A1, 20A2)embodiments is the PSD-Collapsible 20B as shown in FIGS. 10C-10H. Inthis embodiment 20B, penile sleeve device only comprises a maincomponent MC 22 so there is no internal component IC 24. In thisembodiment 20B, the proximal end flange 22E′ comprises acollapsible/expandable chamber 22EC in fluid communication with thepocket space 22I which is filled with either liquid or air. With thePSD-Collapsible 20B implanted within the penile shaft PS and the penis Pis in a flaccid state (FIGS. 10C-10E), the majority of the liquid or airremains contained in the medial portion of the PSD-Collapsible 20B, asshown in FIG. 10E and the chamber 22EC is collapsed. However, when thepenis P becomes erect, as shown in FIGS. 10F-10H, the expansion of thepenis girth drives the liquid or air out of the medial portion of thePSD-Collapsible 20B and into the chamber 22EC, causing it to expand asshown in FIGS. 10F and 10G. Since the PSD-Collapsible 20B is a closedsystem, when the penis P returns to its flaccid state, the liquid or airreturns to the medial portion of the PSD-Collapsible 20B.

PSD-Volume Shift 20C

Another PSD alternative is the PSD-Volume Shift 20C as shown in FIGS.10I-10O. This embodiment is somewhat similar to the PSD-Collapsible 20Bbut instead of transferring liquid or air within the PSD itself, theliquid or air is transferred between an external reservoir R and thePSD. Like the PSD-Collapsible20B, the PSD-Volume Shift 20C comprises noIC 24. In this embodiment 20C, the proximal end flange 22E″ comprises aninternal passageway that is coupled to, and in fluid communication with,a connecting tube CT which in turn is coupled to the external reservoirR that is implanted within the patient, e.g., between the bladder andpubic bone (FIG. 10I). The pocket space 22I is filled with either liquidor air such that when the penis is in the flaccid state (FIGS. 10J-10L),the majority of the liquid or air shaft PS and the penis P is in aflaccid state (FIGS. 10C-10E), the majority of the liquid or air remainscontained in the medial portion of the PSD-Volume Shift 20C, as shown inFIG. 10L and the external reservoir is in a collapsed state, as shown inFIG. 10K. However, when the penis P becomes erect, as shown in FIGS.10M-10O, the expansion of the penis girth drives the liquid or air outof the medial portion of the PSD-Volume Shift 20C and into the externalreservoir R, causing it to expand as shown in FIGS. 10M and 10N. Sincethe PSD-Volume Shift 20C is also a closed system, when the penis Preturns to its flaccid state, the liquid or air returns to the medialportion of the PSD-Volume Shift 20C.

P SD-Spoke 20D

Another PSD alternative is the PSD-Volume Shift 20C as shown in FIGS.10P-10R. Like the PSD-Collapsible 20B and the PSD-Volume Shift 20C, thePSD-Spoke 20D comprises no IC 24. In the PSD-Spoke 20D, a plurality ofradial spokes SPK are arranged between the MC inner layer 22S1 and theMC outer layer 22T1. Each of these spokes SPK can “collapse” of“flatten” when an outward radial force is applied; e.g., each spoke SPKmay be pivotally mounted on one end to either the MC inner layer 22S1 orthe MC outer layer 22T1. Thus, with the PSD-Spoke 20D implanted withinthe penis P, when the penis is in the flaccid state (FIG. 10Q), theradial spokes SPK are substantially radial in direction as shown in FIG.10Q. However when the penis P becomes erect, as shown in FIG. 10R, theexpansion of the penis girth drives inner layer 22S1 towards the outerlayer 22T1, thereby causing the spokes SPK to “collapse” as shown inFIG. 10R. When the penis P returns to its flaccid state, the spokes SPKare biased to restore to their substantially radial position as shown inFIG. 10Q.

PSD-Insert 20E

Another PSD alternative is the PSD-Insert 20E as shown in FIGS. 10S-10V.Like the PSD-Collapsible 20B, the PSD-Volume Shift 20C and the PSD-Spoke20D, the PSD-Insert 20E comprises no IC 24. In the PSD-Insert 20D, theMC comprises a plurality of distinct portions: a distal portion MC-DIST,an insert portion INS and a proximal portion MC-PROX. Each of theseportions comprises corresponding coupling members, namely, the distalportion MC-DIST and proximal portion MC-PROX comprise respective collarsCOL that mate with receptacles REC in respective ends of the insertportion INS. To accommodate different sized penises, insert portions INSof different sizes can be coupled between the distal portion MC-DIST andthe proximal portion MC-PROX.

PSD-Telescoping Design 20F

In this PSD embodiment, the main component MC 22 comprises two distinctportions that slide over the IC 24. In particular, a distal telescopingportion MC-Tl and a proximal telescoping portion MC-T2 slide over the IC24 (FIGS. 10W-10X), between inner layer 22S1 and outer layer 22T1 ofeach of the telescoping portions MC-T1 and MC-T2, as shown in FIGS.10Y-10Z. Like the PSD-Insert 20E, the PSD-Telescoping Design 20F allowsfor the length of the PSD to be adjusted in accordance with the penis ofthe particular patient.

PSD-Fused

The PSD-Fused embodiment is similar to the PSD-smooth embodiment 20 butwhere the MC 22 and the IC 24 are fused together (e.g., melted) to forma unitary member. As such, there is no need for the dorsal mid-line slit22J.

PSD-12 Inch

The PSD-12 Inch embodiment is similar to the PSD-S-fold embodiment 20Abut only comprises the main component 22 as a single layer element. Thisdevice has a standard 12-inch length. When a patient is measured, thedevice will be cut down to size to fit the patient's penile length.

PSD: Suture Clips 80

As shown in FIG. 2E, Suture Clips 80 are small U-shaped pieces ofplastic that will be used to protect the PSD 20 from the pressure of thesutures S. The Suture Clips 80 will be placed into the suture slits22N/24G, like “straddling” the paired slits. Once placed, the sutureknots will lie directly on the Suture Clips 80, not the PSD 20 siliconematerial. Without the Suture Clips 80 protecting the more fragilesilicone rubber material, the suture S material would dig into andburrow through the silicone material over time and thereby destabilizethe PSD 20.

PSD: Sutures S

The Sutures S used to mount the PSD 20 to the penile fascial tissueswill be a non-dissolvable, very durable, strong type of Urologicalsuture currently used in surgery.

PSD for Partial, Optimal, or Supra-Optimal Penile Flaccid Lengthening

If the patient has a flaccid length of 2-inches, and an erect length of6-inches, he has the option to increase the flaccid length to 3, 4, or5-inches, and this would be considered partial flaccid lengthening. Ifthe patient desires a 6-inch flaccid length, which would match hiscurrent erect length, this would be considered an optimal flaccidlength. Anything below 6-inches is considered a partial flaccidlengthening, and 6-inches will be considered optimal flaccidlengthening. If the patient wants to out-stretch the penis beyond the6-inch range, let's say to 7 inches, this would be consideredsupra-optimal flaccid lengthening. There are PSD design differences toachieve partial and optimal flaccid lengthening.

The PSD 20 for partial flaccid lengthening comprises the MC 22 with theIC 24 for support, if needed. The PSD 20 results in lengthening of theflaccid penis by preventing the retraction or recoil forces of thepenile tissues. These retraction forces originate from evacuated penileblood from the erect to flaccid state, muscle cell contraction, elasticand collagen fiber contraction, all of which are found within the penilestructure. The PSD 20 flaccid length chosen for implantation willcorrespond to the patient's desired flaccid length gain. The PSD 20 isinserted and then anchored at the distal shaft, also called thesub-glans area (SGA). There is a tapering of the PSD 20 at the proximaland distal ends, so during the flaccid state or upon erection, the PSD20 is near invisible and impalpable, not being able to feel any elevatedends of the device 20 through the penile skin. It should be noted thatthe general concept is to have both, the PSD 20 inserted in combinationwith having a filler treatment (FIG. 8A). The reason for the fillertreatment is not only to provide girth to the penile shaft, but also tocompletely conceal the PSD 20, so that the PSD 20 may be imperceptibleif carefully “looked for”. Therefore, the filler treatment not onlyincreases girth, increases the flaccid length to a modest degree, but italso provides a collagen layer within and just under the dermal spaces,26, providing a natural skin tissue-like feel to “hide” the PSD (seeFIG. 8A). The Proximal End Flange 22E of the MC 22 might be eliminatedfrom the PSD 20 design if the flaccid length desired is below theflaccid optimal or supra-optimal lengths. If this is the case, theProximal End Flange 22E might be modified or ‘cut off’ as needed. Notethat to determine the segment of the penile shaft to which the PSD 20will be placed and sutured to requires the penile shaft be artificiallyerected, then the penile shaft flaccid segment length that is desiredwill be marked off regarding suture zones, then PSD 20 will be placedonto that area. Once the PSD 20 is placed, the artificial erection isrelieved, and the entire penile shaft, except the mounted segment by PSD20, will contract and shrink. Also note that normal flaccid lengths needto be determined so an accurate final result can be achieved. Forexample, if the patient has a 3 inch flaccid length, and a 12 inch erectlength, and desires to hang 9-inches flaccid, mounting the PSD 20 to 8distal outstretched penile shaft inches will result in a final flaccid9-inch length. This will be calculated by knowing that each 1 inch offlaccid length expands 4 inches (3 flaccid inches expanding to 12 incheserect), so if the distal 8-inches of the erect length are mounted withthe PSD 20, that will leave only 1-inch of flaccid length left. So, themounted 8-inch segment, once the erection has been removed, will remain8-inches long, and the other 4 inch erect segment will shrink down to1-inch; and this will total to a 9-inch flaccid length, just what thepatient desired.

The PSD 20 for optimal and supra-optimal flaccid lengthening comprisesthe MC 22 and the IC 24 for support; in addition, the PSD 20 will needthe Proximal End Flange 22E to “butt up” against the pubic bone andligaments. The depth of the pubic pocket space 50 may exceed the lengthof the Proximal End Flange 22E, and in these cases a Proximal Extension(PE) will be needed to lengthen the Proximal End Flange 22E to fitwithin the pubic space to ultimately abut up against the pubic bone andligaments. The PE length needed will vary depending on the amount ofexisting proximal anatomic “pocket” space by the pubic bony PR area. SeeFIG. 8E where the reference number 10 indicates a region that may beoccupied with ligament and tissues which may limit the Proximal EndFlange 22E length. The PE, which abuts up against the pubic bone areaPR, is very important to stabilize the PSD 20 from proximal movement.The PSD 20 will need to be limited in extending or moving proximally,especially on the ventral side. Ventral proximal movement of PSD 20 willpotentially impinge on sensitive ventral structures such as the penileurethra, corpora cavernosa, corpus spongiosum, etc., and this needs tobe avoided. The space on the proximal dorsal penile shaft pubic area isoccupied by the PSD 20, thereby preventing any further proximal motionof the PSD 20 and thereby protecting the ventral proximal edge of thePSD 20 from impinging on sensitive penile tissue structures. The PSD 20is custom fitted to extend into that pubic pocket space. The proximalextension flange 22E of the PSD 20 is very important for optimal flaccid(and erect) lengthening stabilization, and for anatomic medical safetyreasons, as discussed. Furthermore, the following terminology isimportant to PSD 20 operation:

-   -   Erect Length: Partial or Optimal erect lengthening    -   Flaccid Length: Partial, Optimal, Supra Optimal    -   Flaccid Penis: Out-stretched, Hyper-Stretched    -   Penile hardness/firmness—low, moderate or high    -   Functions: Length, Girth, Firmness (ED), Curvatures, Custom,        flaccid length maximization    -   Firmness—Low, Moderate, High    -   Retraction forces: evacuated blood, muscle cell contraction,        elastic and collagen fiber contraction, and overstretched        muscle-collagen-elastic fiber components.    -   Penile Curvature—Mild, Moderate    -   Penile Curvature Degree ranges; Non-Pathological 5 to 20,        Pathological 5 to over 90

Careful measurements are taken to accurately and properly place theappropriately length PSD 20 for optimal or supra-optimal flaccidlengthening. To accomplish the patient PSD 20 “fitting”, severalmeasurements need to be taken including, but not limited to:

-   -   Flaccid “contracted” state girth    -   Flaccid fully out-stretched flaccid state girth    -   Flaccid hyper-stretched state girth and length (stretching        beyond the normal erect length)    -   Erect: induced erect penile state length and girth    -   Erect: length and girth during a hyper-stretched erect state    -   Degloved: flaccid girth    -   Degloved: flaccid out-stretched girth    -   Degloved: flaccid hyper-stretched girth    -   Degloved: erect girth    -   Degloved: hyper-stretched erect girth and length    -   Degloved: obtaining measurement of depth of ‘pubic pocket’        (measuring to base of penile tissue to pubic bone).

FIGS. 6-6E provide functional diagrams for determining penis length andgirth for different conditions of the penis enumerated above.

FIG. 6 sets forth the penile parameters for the erect penis. The erectgirth is determined as shown by EGM. The proper way to obtain the erectpenis length is to take measurements along the dorsal and ventral sidesfrom the pubic bone to the glans-shaft junction, namely, ELDS and ELVS,respectively. With regard to the ventral side measurement ELVS, thatmeasurement is taken 1 inch away from the peno-scrotal junction. Inaddition, the overall length EOL from the pubic bone to the meatus alongthe dorsal side is also obtained. It should be noted that the ventralerect measurement (normal erect and hyper-stretched lengths) iscritical. All PSD 20 sizes are selected for patient implantation by thisventral length measurement. For example, if a patient has a dorsal erectmeasurement of 6 inches, but has a ventral erect measurement of 4.5inches, then a PSD 20 with a ventral length of 4.5 inches will beselected. The PSD 20 sizes for manufacturing will go by ventral erectlengths. Now, that being said, if the flaccid penile shaft is stretchedout to determine how much erect length can be achieved, the measurementwill be taken from the ventral shaft glans junction and 1-inch away fromthe peno-scrotal junction. This is how a PSD will be selected in apatient who wants erect length increase. Again, the PSD 20 will “sit”just below the glans on the distal end, and cannot encroach upon thesensitive peno-scrotal tissues on the proximal end (and this is why a1-inch ‘buffer’ is provided so the proximal ventral side of the devicewill not be in direct contact with these tissues).

FIG. 6A sets forth the penile parameters for the hyperextended flaccidpenis. Before any measurements are taken, the flaccid penis is pulled bythe glans to stretch out the penis which results in a length that islonger than the erect penile length. For example, if the penile erectlength is 6-inches, the hyper-stretched flaccid penis may stretch out to7-inches. The hyperextended girth is determined as shown by HEG. Theproper way to obtain the hyperextended penis length is also to takemeasurements along the dorsal and ventral sides from the pubic bone tothe glans-shaft junction, namely, HELDS and HELVS, respectively. Withregard to the ventral side measurement HELVS, that measurement is alsotaken 1 inch away from the peno-scrotal junction. In addition, theoverall length HEOL from the pubic bone to the meatus along the dorsalside is also obtained.

FIG. 6B sets forth the penile parameters for the flaccid penis. Theflaccid girth is determined as shown by FG. The proper way to obtainflaccid penis length is to take measurements along the dorsal andventral sides from the pubic bone to the glans-shaft junction, namely,FLDS and FLVS, respectively. With regard to the ventral side measurementFLVS, that measurement is taken 1 inch away from the peno-scrotaljunction. In addition, the overall length FOL from the pubic bone to themeatus along the dorsal side is also obtained.

FIGS. 6C-6E are directed to measurements taken of the penis when it isin a degloved condition, meaning that the penile skin PS has been pulledback exposing the penile fascia of the penile shaft PS. As such, thegirth of the degloved penis can be determined. The flaccid girth state(FIG. 6C) has three measurements: normal flaccid, out-stretched, andhyper-stretched states. The flaccid girth state is measured is in itsnormal flaccid state (in its normal contracted state), its out-stretchedstate (pulling the glans until reaching erect length), and itshyper-stretched state (pulling the glans and reaching beyond the erectlength). The flaccid length has two measurements: the flaccid length,(the out-stretched flaccid length is equivalent to it erect length, sothis measurement is not needed), and the hyper-stretched flaccid length.The erect girth state has two measurements: erect (FIG. 6D) andhyper-stretched (FIG. 6E), using the same length parameters describedabove with regard to FIGS. 6-6B.

Erect measurements are taken by inducing the erection via injection. Thepenile shaft is injected with saline to create an artificial erection.Then, with certain measuring instruments, penile measurements are taken.The PSD 20 length is then modified if necessary. Then PSD 20 is insertedand anchored at the distal penile shaft area. The PSD 20 results inoptimal or supra-optimal lengthening of the flaccid penis by preventingthe retraction or recoil forces of the penile tissues.

PSD 20 for Partial or Optimal Penile Erect Lengthening

Penile erect lengthening can be either partial or optimal. Partial oroptimal length is determined by how much “stretch factor” there is ofthe penile tissues. By way of example only, a patient has an erectlength of 6 inches, but it can stretch, when physically pulled, to8-inches. The patient may opt to increase the erect length to 7-inches,thereby requesting a “partial” erect length gain. If the patient opts toincrease the penile erect length to 8-inches, this would be consideredan “optimal” erect length gain.

There are minor PSD 20 design differences to achieve partial and optimalerect lengthening. The PSD 20 for partial erect lengthening comprisesthe MC 22 with the IC 24 for support. The PSD 20 has a key supportiverole in keeping the penis in an elongated erect length, being abutted upagainst the pubic bone and ligaments and preventing the PSD 20 fromproximal movement.

Careful intra-operative measurements are taken to accurately andproperly select and tailor the PSD 20 for partial erect lengthening. Toaccomplish the size selection of the PSD 20, penile shaft flaccid anderect measurements are taken with and without saline injections. Then,with certain measuring instruments, an accurate natural erect length canbe obtained. The erect penis is then relieved and resumes its flaccidstate. Then, the flaccid penis is out-stretched beyond the erect lengthand measured to determine what additional erect length can be achieved.Once the PSD 20 length has been selected, placement can proceed.

In addition, considering that there could be additional retractionforces due to overstretching the penile tissues beyond the normal erectlength, the PSD 20 may be designed with a higher durometer and/or withmore thickness, and more anchor suture anchor locations in addition tothe distal sub-glans anchoring suture anchor locations as needed. ThePSD 20 causes partial lengthening of the erect penis by not onlypreventing the normal retraction or recoil forces of the penile tissues,caused by muscle cell contraction, elastic and collagen fiber retractionforces, etc., but also by exerting extra force to counter the nowhyper-extended, now extra, recoil forces by these same elements.Additional recoil forces may be experienced when the erection processoccurs, with blood flow into the penile shaft, on an outstretched penis.The blood enters into the corpora cavernosa CC and attempts to fill itschamber to not only capacity, but also may want to “shorten” to itsoriginal shape. It is analogous to trying to fill an outstretched roundballoon with air: the balloon fills to its new stretched out form, butit “wants” to return to its normal round shape and so additional forcesmight be generated with an out-stretched penis onto the PSD 20.

The PSD 20 for optimal erect lengthening comprises the MC 22 and the IC24. The PSD 20, with the appropriate MC 22 and IC 24 thickness anddurometers, and proper location and quantity of suture locations, amongother aspects, is very important for optimal erect lengthening and foranatomic medical safety reasons. The PSD 20 is measured accurately. Thepenile shaft is injected with saline to create an artificial erection,then, with certain measuring instruments, an accurate natural erectlength can be obtained. The erect penis is then relieved and resumes itsflaccid state. Then, the flaccid penis is out-stretched beyond the erectlength optimally and is measured to determine what maximal additionallength can be achieved. Once the PSD length has been selected, placementcan proceed.

The PSD 20 causes optimal lengthening of the erect penis by not onlypreventing the normal retraction or recoil forces of the penile tissues,caused by muscle cell contraction, and elastic and collagen fiberretraction forces, but also by exerting an extra force to counter thenow maximized hyper-extended extra recoil forces, as already mentionedprior. Additional recoil forces may be experienced when the erectionprocess occurs, with blood flow into the penile shaft, on anoutstretched penis. The blood enters the corpora cavernosa CC andattempts to fill its chamber to not only capacity, but potentially toits original shape.

Considering that the PSD 20 exerts a force on the penile tissues, thisstretching force will, over time, stretch out the penile tissues,including the collagen, elastic, and muscle fibers, and result in apermanently stretched out penile shaft. Perhaps over a 6-12-month timeperiod, the penile tissues will have stretched, now exerting little tono more recoil tension on the PSD 20. This new “stretched-out state”provides the patient with the option to “re-stretch” the penile shaftagain to see if additional erect length can be obtained. This involvesremoving the original PSD 20 and placing in a new and longer PSD 20.

PSD and Penile Girth or Thickening

Most patients want a combination penile length and girth increase. Theprimary function of the PSD 20 is to increase penile flaccid and erectlength, and the permanent filler is primarily for increasing penileflaccid and erect girth. Since the PSD 20 inherently provides somegirth, due to its space-occupying physical characteristics, there aresome simple design modifications that can be made to “optimize” thissecondary girth function without causing cosmetic tissues. The PSD 20canbe made with varying thicknesses resulting in significant girth gains.However, the PSD 20, if designed to be made much thicker, may introduceincreased risks of skin irritation, with the potential of additionalcomplications, and may not be cosmetically pleasing to the touch,especially at its distal, proximal, and proximal ventral “edge”locations (if the PSD 20 is larger in general, the edges may not be easyto conceal form detection). These are the very issues other prior artpenile implants on the market are having. Many patients with theseimplant devices are having them removed due to pain and having anunnatural feel. In contrast, the objective of the apparatus and methodof the present invention, in combination of the permanent fillertreatment process, is an overall enlargement process that is twofold:use (1) the PSD 20 for primarily lengthening, and (2) the permanentfiller for primarily thickening. Considering that the PSD 20 is placedbelow the Dartos Fascia DF and above Buck's Fascia BF, it would be idealto strengthen the tissues above the PSD 20 including this Dartos FasciaDF and penile skin PSK. This marriage between the two processes (PSD 20and filler treatments) will not only address and keep the PSD 20“bulkiness” to be minimal, resulting in less irritation and stress onthe penile tissues, but also results in the permanent filler generatingnew collagen production, which will not only provide girth, but alsothickens and “fortifies” the normal penile skin PSK dermal collagenlayer and supra and intra Dartos Fascia (DF), thereby providing addedprotection from any type of irritation from the PSD 20. So, thisadditional “fortified”, thickened, and protective newly-formed collagenlayer within the penile skin PSK and Dartos Fascia DF, in conjunctionwith the PSD 20, will form a cooperative and synergic effect.

Most patients desire length and girth increases, but there are a fewpatients who desire only a girth increase, which is an option with thepresent invention. In other words, the patient wants to maintain hisflaccid and erect length, but only increase the flaccid and/or erectgirth. If this were the case, then the way to accomplish a flaccid anderect “girth-only” gain would be to place the MC 22 measuring the lengthof the flaccid penis. The MC 22 is anchored to the distal and proximalends of the flaccid penile shaft. It should be noted that if the flaccidlength is 2-inches, then the PSD 20 will be 2-inches. Then, uponerection, e.g., to a 6-inch erect length, the MC 22 will stretch andthin down resulting in a much thinner form, which will provide somegirth in the erect state, but not optimal. The results regardinggirth-only goals, especially erect girth, will be limited. These limitedgirth gains result from limited PSD 20 thickness, stretchability, andthickness size drop per penile inch stretched. The PSD 20 cannot be toothick because this increases the penile tissue stress from the PSD 20stretching out from the flaccid to erect state, and those generatedstresses are then transmitted to the anchor points and penile tissues,possibly resulting in lowering the PSD 20 longevity and causing patientdiscomfort. Considering this, the patient can be consulted to discussappropriate recommendations to reach the patient's goals.

Increasing penile erect (and flaccid) girth can be broken down into low,moderate, or high levels. If one desires increased erect girth, withobligatory flaccid girth gains as well, then there could be an increasein the thickness of the MC 22 and, possibly, the IC 24, depending on theamount of permanent filler that is going to be considered.

The range of penile shaft girth thickness size that can be obtained withthe PSD 20 ranges between 0.5-8 inches in circumference (not diameter).All girth measurements will be in circumference measurements, notdiameter, and in inches, not in the metric system.

Here is an example, with measurements, of a PSD 20 providing a flaccidand erect girth gain. The average penile flaccid girth is 3.75 inches,and the average penile erect girth is 4.75 inches. This “differential”in girth size, from the flaccid to erect state, is 1-inch incircumference. If a patient desires to add a low girth increase, forexample, a 1-inch erect girth gain, from 4.75 inches to 5.75 inches, thePSD 20 is modified to be approximately 4/16ths of an inch thick in theflaccid state, which will result in a thickness of 3/16th of an inchthick once stretched out in the erect state. So, once an erection takesplace, the penis expands and lengthens causing some “thinning down” ofthe PSD 20. This size drop, or thinning down of the PSD 20, occurs andplays a role in determining what size flaccid PSD 20 is required todetermine the erect PSD 20 girth size. This size thickness PSD 20 yieldsabout a 1-inch erect girth increase, or a 5.75-inch erect girth penileshaft size.

Calculating the circumferential girth gains is in accordance with thecircumference equation, πD, i.e., multiplying the diameter of the PSD 20by π or roughly by 3. So, for example, if there is a PSD 20 of3/16th-inch (erect state) thickness, then the diameter increase is6/16th of an inch ( 3/16th thickness on one side of the penile shaft,and 3/16th of an inch on the other side of the penile shaft= 6/16th ofan inch total), and the circumferential increase is 6/16th inchdiameter×3= 18/16th inch, or just about and slightly over a full inchgain in circumference.

During the flaccid state, the PSD 20 is larger, for example, 4/16th ofan inch thickness, because it is not out-stretched and thinned downduring the expansion of the erect state. The flaccid girth, with a4/16th size PSD 20, yields about a 1.5-inch increase in the flaccidgirth. So, the flaccid girth is 3.75 inches plus 1.5 inches, or aflaccid girth of 5.25 inches. The erect girth, with a 3/16th of an inchsize thickness outstretched PSD 20, results in about a 1-inchcircumferential gain, yielding an erect girth of 5.75 inches. As the PSD20 increases to very large thicknesses, the flaccid girth size willbegin to approach the erect girth size, so eventually the erect state,with the consistent and same amount volume of blood flow during theerection process, will barely increase the erect girth. For example, inthe normal flaccid penis of 3.75 girth, and an erect girth of 4.75girth, if one adds 4 inches of flaccid girth, now being 7.75 inches (or7 12/16ths), the amount of blood entering into the penis is the same.So, the erect girth increase might be 1/16th of in an inch, with aresultant 7 13/16th total erect girth.

The primary component of the PSD 20 that provides for most of the girthis the MC 22. The IC 24 can provide significant girth, but since this isthe “hard” portion of the PSD 20, increases in the thickness of the IC24 are reserved for ED, additional erect firmness, and curvaturecorrection needs. If a patient wants to increase his erect girth from4.5 to 8.5 inches, then if the MC 22 is too thick, it may result in a“soft” feel during the erect state and this is not desirable. In suchcases, the IC 24 will be made thicker to provide some of the girth andensure firmness or hardness is maintained. The MC 22 requiressubstantial thickness not just for providing girth, but also to providecomfort since living tissue does not like long term pressure placed onit by hard substances. So, a delicate balance will need to be consideredwhen very large size PSDs 20 are being used.

PSD and Penile Hardness or Firmness

Penile hardness, or firmness, can be broken down into low, moderate, orhigh. If one desires to add this feature, then there is an increase inthe durometer (and possibly thickness) of the IC 24 and possibly the MC22 as well.

Patients with mild or even moderate levels of erectile dysfunction (ED)issues can benefit from a more firm or harder PSD 20. Currently thereare medical and surgical treatments for ED. When medical treatments failto provide added firmness, such as VIAGRA®, or similar oral medications,or injectable and suppository meds, etc., then there are surgicaloptions such as having an implant placed deep within the penis. Thereare two types of implant devices, the metal rod type, and the balloonpump type. Both of these devices are placed directly into the corporacavernosa (CC) or the deep tissues of the penile shaft. This surgicalprocedure is under general anesthesia because there is deep cutting intothe penile tissues needed to place the device. This deep cutting willresult in significant penile tissue damage specifically to the finesinusoidal architecture SA of the cavernosa. After placement of thesedevices, and permanent irreversible damage done, there is no turningback; patients must now rely on this system for the erection process forthe rest of their lives. In addition, the balloon implants canmalfunction, break, etc., which would then need to be replaced, therebyresulting in another operation with the same risks of infection,anesthesia, etc. Over all, and even considering the risks involved,these metal rod and balloon systems provide very good treatment optionsfor those with moderate ED.

As an alternative treatment for low to moderate levels of ED, the PSD 20has an optional design feature that can provide greater firmness andthus help with ED support. This PSD 20 can provide a lower risk optionfor patients with mild to moderate forms of ED. The benefits of usingthe PSD 20 for ED include; not causing permanent damage to the corporacavernosal CC tissues; and no need for general anesthesia, andassociated risks associated with it, in most cases; and, lastly, the PSD20 is placed only skin deep, in the subcutaneous space, and easy toremove if needed, without the need to cut deep into the penile tissues.

PSD and Penile Curvature Correction

If the penile shaft is not straight during an erection, the penile shafthas a curvature. Penile curvatures can be classified as mild ormoderate. Curvatures can occur naturally or pathologically (caused by adisease or traumatic process, for example). Curvatures can also occur ina variety of locations on the penile shaft, and directions. Curvaturedirections include a dorsal (upward) curve, a ventral (downward) curve,a right or a left curve, twisted or spiral type curve, or anycombination thereof. Curvatures can also be located at particularsegments of the penile shaft, such as at the penile base (proximalarea), or at the shaft mid-section, or distal shaft area, or acombination thereof. Natural curvatures are generally mild, not inmultiple locations, and curve from 5 to 20 degrees. Pathologicalcurvatures can range from a 5 to over 90 degree curvature and be foundin more than one location on the penile shaft.

If one desires to correct the curvature, the PSD 20, with certain designchanges, can help. To assist in curvature correction, an increase in thedurometer (and possibly thickness) of the IC 24 is made and possibly inthe MC 22 as well. In addition, a SIC 24J (FIG. 10A) can assist tocounter this curvature force. The SIC 24J does not necessarily have tobe the same length, durometer, or thickness as the IC 24, but can becustom tailored for the need presented. For example, if the penile curveoriginates at the mid-section of the penile shaft, then the SIC 24J, ifneeded, is placed at the mid-section of the penile shaft which wouldprovide additional “straightening” support at that specific location. Ifthe SIC 24J is added, it will be, in general, much shorter in lengththan the IC 24. The objective of the SIC 24J is for “target” treatment,so its length will be appropriate for the need. This extra supportprovided by the SIC 24J, whether a partial or full-length support (ifneeded), helps counter the curvature force directly where it occurs. TheSIC 24J can be placed on top of the IC 24 and mounted, with sutures ifnecessary, to assist in stabilizing this PSD 20, preventing the SIC 24Jfrom sliding out of position. The mounting technique for the SIC 24J tothe IC 24 and MC 22 may vary. One option is to simply place the SIC 24Jon top of the IC 24, both using the same pocket space 22I within the MC22 for stabilization. Another technique can be suturing the SIC 24J toIC 24, or suturing the IC 24 and SIC 24J to the MC 22 as well, etc.

PSD and Penile Custom Shape

Custom penile shapes can vary and be numerous. For example, a patientmay desire a “veiny” look, which would require adding “veins” 22F to thesuperficial aspects of the MC 22 mold. Some patients may want specificasymmetries, such as an increased proximal to distal shaft thickness, oreven a mid-shaft thickening. Other custom shapes, such as having “bumpouts” 22G like implantable “pearl like” effects, can also be possible.

Another special case is with patients who are not circumcised. RegardingPSD 20 placement, the circumcision status is not relevant, however, ifpermanent filler is going to be used at a future date to increase penileshaft girth, then it is recommended to get a circumcision prior or afterPSD 20 placement, and before permanent filler placement. The patient,however, still may opt not to get a circumcision. In this situation, thepatient can have the PSD 20 placed, but if the patient wants permanentfiller treatment afterwards, the resultant collagen production may onlyprovide little to no girth increase in the distal shaft area, where theforeskin is, in some cases. The area that the foreskin resides on thepenile shaft, once erected, occupies approximately one to two fifths ofthe distal penile shaft. Considering this, the patient may opt to modifythe PSD 20 to have improved and more symmetrical balance, if needed, byincreasing the distal girth of the PSD 20. This increase will helpbalance out this potential filler deficit, or area that not much fillercan be placed, at the distal one to two fifths penile shaft area.Another remedy would be to add a SIC 24J just at the distal one to twofifths of the PSD 20 to compensate for the disproportion and asymmetricnarrowed area due to the little to no girth gain in that area.

PSD: Penile Flaccid Elongation with Girth

The PSD 20 is designed to be a stand-alone device, providing flaccidlength and girth, but primarily length with girth to a certain extent.For example, if the PSD 20 is too large (thick), providing the entiredesired girth size, which size can be substantial, it may becomeuncomfortable, palpable to the touch, and increase the risk of skinirritation. Therefore, it is recommended that a filler technique be used(to meet the girth goals) in conjunction with the PSD 20, which wouldmeet the primary length goals. The filler, which results in collagenproduction, such as that disclosed in U.S. Pat. No. 9,993,578 (Loria),whose entire disclosure is incorporated by reference herein, not onlyprovides the additional girth needed but also provides a naturalcosmetic feel and structural support for the penile shaft skin. Thisstructural support is formed by; additional collagen formation withinthe existing natural dermis collagen, in the immediate penile skinsubcutaneous area, and the physical attachment of this subcutaneouscollagen to the undersurface of the penile skin or dermis. This“‘physically attached” collagen would now be in direct contact with thePSD 20, not the natural penile dermis. This structural support, with allthis new collagen in and under the penile skin, will help preventpotential minor skin irritation, inflammation, etc., by direct contactof the PSD 20 on this area. If the patient prefers not to have anypermanent filler placement but only place the PSD 20, and finds that thePSD 20, once inserted, feels natural and comfortable, then no furtherfiller treatments will be needed.

The PSD 20, used for flaccid elongation, will typically encounter mildto moderate retraction or recoil forces by the flaccid penile shaft. Forexample, a patient who wants to optimize his flaccid length, with onlyan obligatory girth gain from the PSD 20, has measurements of: flaccidlength of 4-inches, erect length of 5-inches, and an erect girth of 4.75inches. In this case, the patient desires to have a flaccid length of 5inches with an erect girth of 4.75, or as close to that as possible.There is an obligatory minimal thickness of the PSD 20 (a thin MC 22and, if needed, a thin IC 24) providing a mild counter force needed, toaccomplish the full 5-inch goal since the retraction force is minimal(only stretching from a 4 inch to a 5-inch length). The erect andflaccid girth increases some, because even though the PSD 20 is as thinas possible, there still is an obligatory ½ to ¾ inch gain in girth.

Another example is a patient who wants to optimize his flaccid length(or have supra optimal flaccid lengthening) with a minimal girth gainhas measurements of; flaccid length of 1-inch, erect length of 8-inches,and an erect girth of 5 inches. Considering there is a lot of retractionforces to counter, the PSD MC 22 will be thicker, and the IC 24 is goingto be, most likely in this case, thicker to help counter this moderateto high flaccid penile retraction force. Additional anchors may be used.The length goal is achieved; however, the patient may gain an obligatory1 to 1.25 inches in girth simply due to the inherent nature of thedevice having increased girth itself due to the increased thickness ofthe PSD 20 which is needed to withstand the retraction forces. If any ofthe aforementioned patients wanted any additional girth, reaching themoderate to high sizes, the MC 22 thickness would increase and/or morefiller would be placed. Additional suture anchors are placed as needed.Note that supra optimal flaccid lengthening would increase the flaccidlength to 9 or more inches and would also increase the penile erectlength which would now require additional structural and retractionforce support.

PSD: Penile Erect Elongation with Girth

The PSD 20 withstands a greater force when erect elongation is desired,as opposed to the relatively minor retraction forces encountered withpartial or optimal flaccid elongation. Considering this, an overallthicker and harder PSD 20 is required. The MC 22 is thicker with ahigher durometer, if needed, and this will provide the additionalstructural support in addition to the inwardly-directed radial force or“gripping force” needed on the penile fascia to maintain the partial oroptimal erect length increase. The IC 24 provides additional support toPSD 20 in withstanding the retraction forces, and prevents the MC 22from folding on itself, buckling, etc. This IC 24 also provides forfirmness to the touch, considering its much higher durometer, and addedgirth, if needed, on a case by case basis.

Some examples to demonstrate the concept of penile erect elongation areas follows: A patient wants a partial erect lengthening with girthenhancement. His measurements are: flaccid length 3 inches, erect length6 inches, erect girth 5 inches, and an optimal out-stretched penilelength of 8-inches. In this case, the patient wants to be 7-inches inerect length (a partial erect lengthening), and 6.5 inches in girth.Considering these desired patient parameters, there will need to be amoderate thickness and moderate durometer hardness of PSD 20 because thePSD 20 will encounter moderate to high retraction forces and will needto provide the desired girth increase as well.

Another example involves a patient who wants optimal erect length andincrease erect girth to 6.5 inches. His measurements are: flaccid lengthof 4-inches, erect length of 5-inches, erect girth of 4.5 inches, and anout-stretched flaccid penile length of 6.5 inches. In this case, therewill need to be a PSD 20 with high thickness to meet the girth goal, anda high durometer to counter the moderate to high retraction forces toaccomplish the optimal 6.5-inch erect length and a 6.5-inch girth goal.

Another example involves a patient who wants optimal erect length with a7.5-inch girth. His measurements are: flaccid length of 1-inch, an erectlength of 8-inches, erect girth 5 inches, and an out-stretched flaccidlength of 9.5 inches. Considering that there is an excessive retractionforce to counter, the PSD 20 will need to be thicker (providing girthand structural support as well) and have a higher durometer to helpcounter this high penile retraction force and provide the girth gainsdesired. The MC 22 will be thicker, to accommodate for the girthincrease, and an increase in durometer will also be needed; and the IC24 will have a high to very high durometer with the appropriatevariations in thickness. Additional suture anchors are placed as needed.

PSD: Materials

PSD 20:

-   -   Main Component 22: Medical Grade Implantable Silicone Elastomer    -   Internal Component 24: Secondary Internal Component 24J,        Proximal Extension flange 24D: Medical Grade Implantable        Silicone Elastomer with the possible addition of other        bio-materials such as malleable metal alloys are used, such as        aluminum, lead, gold, silver, platinum, copper, etc. or        combination thereof. Plastic materials may be used as well.    -   Plastic Suture Clips: Medical Grade Implantable Plastic        Component or similar bio-implantable material.    -   Sutures: Non-Absorbable type.

Delivery Devices

-   -   Glans Gripper Device 28: Silicone rubber, metal, and plastic.    -   T-Device 30: Silicone rubber, metal, and plastic.    -   Bio-Degradable Lubricant: Medical Grade Sterile Carboxymethyl        Cellulose or other types.    -   Silicone Oil Lubricant: Medical Grade Sterile Silicone oil.

It should be noted that the malleable metal alloy that may be used inthe PSD 20, specifically the IC 24 to achieve greater hardness andstructural support, and in the MC 22, and/or the proximal extensionflange 22E, to achieve a certain firmness or hardness, in addition toassist in proper penile angulation for the ED patient during the erectstate, which would be angled upwards, and the flaccid state, which wouldbe angled downwards.

PSD: Durometer

The MC 22 has a very low to moderate durometer, low to high thickness,and very stretchable. These characteristics allow for patient/tissuecomfort, expandability during an erection, during penile stretching orbending, low stress on pressure points (distal glans rim area forexample) and protects against the potential irritation caused by thehardness of the Internal Component.

The IC 24 has a moderate to very high durometer, low to high inthickness, and has mild to moderate flexibility. The IC 24 providessupport and hardness to the PSD 20 as a whole. These characteristicsallow for a normal firm/hard feel in the erect state, provide support tothe MC 22 preventing folding, buckling, etc., and provide the counterforce to the penile retraction.

PSD: Thickness

The thickness of the PSD 20 varies for certain circumstances. Forexample, the primary concern is to have the MC 22 and the IC 24 thickenough to achieve the lengthening goals and provide girth as a secondarygoal. When additional girth is desired, then some thickening of thesecomponents provides some, and potentially all, of the desired girthgain. It is difficult to determine if the PSD 20 can provide all of thegirth a patient may want without the PSD 20 becoming too large,resulting in feeling unnatural and/or uncomfortable. To address thisconcern, use of a permanent filler treatment may need to be provided tobalance out these issues. The concept is to use the PSD 20 as a primarylengthening device, with some girth as a secondary aspect, and thensupplement with permanent filler to reach the desired full girth goal,such that, the final results regarding length, girth, and feel meet thepatient's expectations.

The thickness of the MC 22 is, in most cases, greater than the IC 24.The IC 24 may be thicker than the MC 22 in certain circumstances such asin a PSD 22 for ED, or simply a patient's desire to be very firm in theflaccid and erect states.

The thickness of the MC 22 and the IC 24 varies from proximal to distalend due to the need to narrow down, or taper. Other areas of the tubularsections 22/24 are tapered as well, especially in the areas where the IC24 fits into the pocket 22I of the MC 22.

Excessive thickness, which may increase the inwardly-directed radialforce, is avoided because the pressure differential must be maintainedfor erection purposes. If the thickness (or hardness) of these devicecomponents are too high, then the pressure needed to get an erectionmight not overcome this external inwardly-directed radial force and thusresult in a limited erection or blood volume flow into the corporacavernosal CC tissue.

Different thickness ranges and certain aspects considered:

-   -   Main Component 22: 2 to 20 mm thick.    -   Internal Component 24: 0.5 to 10 mm thick. These ranges provide        for all scenarios of erect lengthening, girth, and hardness        goals.    -   Penile retraction forces and desired penile length govern the        thickness and durometer of the MC 22 and the IC 24 components.        Higher durometer and thickness sizes are used with higher        retraction forces and longer penile lengths.    -   The flaccid thickness of the PSD 20 is thinned down upon        erection, due to the PSD 20 being out-stretched in a        circumferential manner. This thinning down effect is calculated        appropriately to provide an accurate erect girth size.    -   The normal or average diameter of an erect penis shaft is        approximately 1.5 inches or 3.8 cm. The average circumference is        4.75 inches or 12 cm. If a 4 mm (diameter) thick device is        placed, it increases the flaccid girth by 1-inch or        approximately 2.5 cm. However, when erect, the PSD 20 thins        down, possibly by 50% (depending on the amount of normal blood        flow into the penile shaft during the erection process), so the        erect girth decreases to about ½inch or 1.25 cm.    -   If the MC 22 is too thick, and the IC 24 is too thin, it may        compromise the final erect firmness. The exact sizes for the MC        22 and the IC 24 are determined intra-operatively by creating        artificial erections, via saline injection, and external        palpation of the PSD 20. The remedy for increasing erect        hardness is simply by increasing the IC 24 thickness and/or        durometer, decreasing the MC 22 thickness, or increasing the MC        22 durometer.    -   The MC 22, in most cases, is the thicker component. It is also        flexible, and stretchable. These aspects are key for the penis        to become erect without a significant opposing inwardly-directed        radial force, and to have a soft device in contact with the        penile tissues for comfort and to eliminate irritation and        chronic pressure.

PSD: Shape Edges

-   -   Any portion of the MC 22 and IC 24 directly or indirectly in        contact with the penile tissues have smooth and rounded edges.        In addition, tapered/rounded zones or areas, such as 22P, 22ET,        22DT, 220T (FIG. 1), etc., are provided for smooth transitions.        Tapering is provided but not smaller than a tapered edge        thickness of 1-4 mm. Structural integrity of the material and        device as a whole, even in the thinner areas such as the tapered        areas, is maintained so as not to invite unwanted fragmentation,        tearing, etc. at these thinner tapered edges.

PSD: Texture

-   -   The general surface of the PSD 20 is smooth in most locations.        The buckle zone, for example, may have an undulating pattern,        however, the surface of this pattern is smooth and rounded.

PSD: Dorsal Surface

-   -   The dorsal surface of the MC 22 has a dorsal mid-line slit        opening, spanning a certain length from the proximal to distal        end of the MC 22. This slit opening is used to allow the        insertion of the IC 24.    -   Provide cosmetic anatomic venous structure or ‘bumpy’ options        for the dorsal and dorsal/lateral surface of the MC 22.    -   The buckle zone 22L can be seen on the dorsal surface having a        wavy undulating pattern.    -   The proximal end flange pocket 22Q, that will receive the IC 24        proximal end flange 24D, has its own particular surface        architecture. It is designed with elevations and depressions to        receive the proximal end flange 24D, if needed, as a tongue and        groove or elevation and depression type pattern to assist the        proximal end flange 24D and end flange pocket 22Q to lock in        place together.

PSD: Ventral Surface

-   -   The MC 22 also comprises a molded U-shaped portion 22R (FIGS.        9B-9C) along the entire ventral longitudinal length to limit        pressure and accommodate the urethra for urinary and ejaculatory        flow. This U-shaped portion 22R allows urinary flow in the        flaccid and erect states, and allows ejaculatory flow in the        erect state, due to little to no direct pressure placed on the        urethra by the PSD 20. The final erect state pulls on the        U-shaped portion and flattens it some (see FIG. 9C), so the        flaccid design provides for the erect state distorting or        stretching this U-shaped area. This means the flaccid shape        forms more like a very narrow U-shape at first. Then, upon        erection, it widens into a true U-shape.    -   Provide cosmetic anatomic venous structure options for the MC        22.    -   The buckle zone 22L can be seen on the ventral surface having a        wavy undulating pattern.

PSD: Lateral Surface

-   -   A proximal lateral V-cut 220 (in MC 22) and 24E (in IC 24), are        placed at the proximal lateral ends as shown most clearly in        FIGS. 1A and 2G. This V-cut design allows downward movement of        the PSD 20 during downward bending of the penis during squatting        motions. This downward bending motion is necessary, and if this        did not occur, then the PSD 20 would project proximally and push        up against the urethra, spermatic cord, and/or other scrotal        tissues, etc.    -   Provide anatomic venous and ‘bumpy’ structure options 22F/22G        for the MC 22.    -   The buckle zone 22L can be seen on the ventral surface having a        wavy undulating pattern.

PSD: Distal Area

-   -   Rounded edges at the distal end of the MC 22 of PSD 20.    -   Distal tapering of the MC 22 for a natural transition to the        sub-glans area.    -   The Distal Lateral Slit Line 22Z is present to gain access to        the suture anchor slits, 22N, for suturing purposes.    -   Suture anchor slits 22N, to mount (if needed). Additional suture        anchor points can be placed along the MC 22 anywhere along the        penile shaft, with corresponding or additional “lateral slit        lines”, as needed, for access.    -   The pocket space 22I extends within the MC 22 to accommodate and        fit the entire IC 24, including in this distal area.

PSD: Proximal Area

-   -   Rounded and edges at the proximal end 22E, of the MC 22.    -   The Proximal End Flange 22E has no to minimal tapered edges, but        has rounded edges.    -   The pocket space 22I extends within the MC 22 to accommodate and        fit the entire IC 24, including in this proximal area.    -   The proximal end of the MC 22 and IC 24 may be elongated to form        the Proximal End Flange, 22E and 24D, respectively. The reason        for the elongated proximal end is to slide into the pubic facial        plane 40 (FIG. 8E) and “fill” the pubic pocket space near the        pubic bone PB/ligament area for the PSD 20 to advance. This        lengthening will now fill that pubic pocket space and prevent        potential proximal movement for stability, balance, and safety.    -   The MC 22 proximal end will be rounded, or even bulbous, and        non-tapered. This type of bulbous and non-tapered end would be        more advantageous due to the location of this proximal end, deep        under the pubic pocket area where it cannot be “touched” or        “felt.” Also, if the proximal end is wider, it will be able to        withstand higher forces and be able to distribute those forces        over a greater surface area. If the proximal end was tapered,        then it would exert a higher force per unit area on the        bone/ligamentous tissues, and possibly results in pain and        inflammation. If the proximal end is rounded, or bulbous, but        kept non-tapered, the force distribution over a larger surface        area will be greater which will decrease the force per unit area        providing less tissue stress and greater comfort. It will be        desirable for the PSD 20 to fit snugly in the pubic space or,        “fit like a glove”. The PSD 20 is to slide in as far as possible        on the dorsal area and close to or on the pubic suspensory        ligaments. On its ventral side, the PSD 20 is to be close to,        but not on, the scrotal area or penile structures such as the        urethra. This proximal end abutment into the pubic space and        against the pubic bone and ligament, helps lock-in the PSD 20        and prevents proximal movement or sliding of the PSD 20, thereby        maintaining stability of PSD 20 as a whole. If PSD 20 were not        positioned optimally being abutted up against the pubic bone and        ligaments, and was able to slide proximally into deeper areas of        the pubic space, this may result in excessive force on the        distal suture area if the device is ‘pushed’ in a proximal        direction.    -   The MC 22 proximal end flange 22E is designed to be cut to        reduce its length, if necessary, to fit into the pubic        bone/suspensory ligaments space.    -   There is a special “slit like” reception area 24K (FIG. 3) on        the proximal dorsal area of the IC 24 for the T-Device 30 (FIG.        4-4A) to fit into (FIG. 4B). The T-Device 30 will be first        placed through the dorsal mid-line slit 22J of the MC 22, then        moved proximally until it reaches the IC slit 24K. The distal        end 30D of the T-Device 30 will fit onto the IC proximal dorsal        reception slit 24K for the T-Device 30. This “slit like”        reception area 24K is where the T-Device 30 will connect to the        IC 24 and allow the T-Device 30 to push the PSD 20 into the        subcutaneous space of the penile shaft.

PSD: Internal Surface

-   -   The MC 22 has an inner layer 22S1 and an outer layer 22T1 (see        FIG. 1H) on its dorsal and dorsal-lateral areas to form a pocket        space 22I. Pocket 22I will be the space that the IC 24 will fit        into, like a “‘hand-in-a-glove” type fit.    -   The MC 22 inner layer 22S1 has an outer surface 22S3 and inner        surface 22S2. The outer surface 22S3 is in touch with the inner        surface 24L of the IC 24. The inner surface 22S2 is in touch        with the penile tissues, specifically Buck's Fascia BF.    -   The MC 22 outer layer 22T1 has its outer surface 22T3 which is        in touch with the penile tissues, and an inner surface 22T2        which is in touch with the outer surface 24M of the IC 24.    -   The ventral area of the MC 22 is a single layer 22W (FIG. 1H).        The inner and outer layer surfaces 22S1/22T1 are smooth, but        there will be an S-Fold undulating pattern (FIG. 2K) wherein the        inner layer S-Fold is referred to as 951, and the outer layer        S-Fold is referred to as 950. These S-folds 951/950 have an        undulating or serpentine pattern. The folds themselves will have        a smooth surface, but the undulating pattern of the folds will        give them a slightly “bumpy” feel to the finger touch. This        particular configuration forms the PSD-S-Fold 20A discussed        earlier. The PSD-S-Fold 20A will be manufactured as a two piece,        MC 22/IC24 configuration.    -   Variations of these undulating or serpentine patterns are shown        in FIGS. 2J and 2L. In particular, FIG. 2J shows the        PSD-wavy-fold 20A1 wherein the inner layer 22S1 and outer layer        22T1 comprise a less undulating or “wavy” serpentine pattern        which are designated 951′ and 950′, respectively. Similarly,        FIG. 2L shows the PSD-Tight-S 20A2 wherein the inner layer 22S1        and outer layer 22T1 comprise an excessive undulating or        tight-turning serpentine pattern which are designated 951″ and        950″, respectively.

PSD and Penile Intra-Op Testing

The PSD 20 will not contain any visible slits on its outside surface.The only slits to be 2 0 found will be the suture slits 24G in the IC 24which will be hidden from view under the lateral mid-line slit 22Z(FIGS. 2B-2E). Underneath the suture slits 24G and aligned therewith arethe suture slits 22N in the inner layer 22S1 of the MC 22. Certainly, inthose PSD embodiments where no IC 24 is used, the suture slits 22N willbe directly available and concealed under the lateral mid-line slit 22Z.It should be understood that, as an optional design if needed, a 1 mmport slit 240 (FIGS. 2C-2D) may also be provided in the IC 24 for salineinjections to induce an erection during intra-operative testing; thisport slit 240 would also be concealed under the lateral mid-line slit22Z and there would be a corresponding slit (not shown) in the innerlayer 22S1 of the MC 22 to permit passage of the needle for the salineinjection into the penile shaft Ps. Other locations for injection forerect testing will include the proximal ventral side of the penile shaftPS.

PSD and Penile Anchoring

Four or more suture anchoring locations 22N are provided into the distallateral end and possibly additional more proximal locations if needed,of the PSD 20. The sutures S pass through the inner layer 22S1 of the MCsuture slits 22N, and the IC suture slits 24G, and then directly intoand then out of Buck's Fascia BF and the Tunica Albuginea TA of thepenile tissues. Then a knot is formed. This suture S will mount the PSD20 onto the penile tissue and stabilize the two MC/IC 22/24 and keep thePSD 20 from moving during flaccid states, erect states, and duringintercourse. Additional anchoring locations in the MC/IC 22/24 may beprovided to attach or mount the IC 24 to the MC 22 directly.

After suture placement and suture knots are formed, the knots areproperly positioned as to not touch the undersurface of the penile skin.The knots will either be tucked below the MC outer layer inner surface22T2, which knots will also sit on top of the outer surface 24M of theIC 24. The suture knots will never be in contact with the penileskin/dermis or fascia tissues.

Additional anchor locations throughout the PSD 20 length may beprovided. If only distal anchors are used, then only partial and minimaldistal degloving (pulling the penile skin down one half to 1-inchproximal to the circumcision incision, e.g., like partially pulling downa pair of pants) of the penile skin is performed and a decreased risk ofinfection and tissue trauma results (this is desirable).

PSD: Forces, and Tissue Involvement During the Penile Flaccid and ErectStates

The PSD 20, once inserted and mounted, exerts forces onto the peniletissues and vice versa. The objective is to balance these forces toeliminate undue tissue stress and pressure onto the out-stretchedflaccid and erect penile tissues, especially during intercourse orsexual activity.

Flaccid Partial, Optimal, and Supra Optimal Lengthening

-   -   The penile retraction force, which is exerted primarily in the        flaccid state, is countered by the PSD 20 for partial, optimal,        and supra optimal flaccid lengthening. This PSD 20 will provide        a counter force which will be applied and simultaneously        substantially limit or eliminate the PSD 20 direct tissue        tension or pressure on the sub-glans (high risk area) or any        other penile tissue areas. Long term PSD 20 use is accomplished        by the appropriate design characteristics in addition to the        proper selection of material, durometer, thickness, shape, and        mounting techniques.

Erect Partial and Optimal Lengthening

-   -   The penile retraction force, which is exerted in the erect        state, is countered by the PSD 20 for partial or optimal erect        lengthening. This penile retraction force, which is exerted by        the retraction of the out-stretched penile shaft and during the        erection process, is, in some cases, can be high. This PSD 20        will provide a counter force which will be applied and        simultaneously substantially limit or eliminate the PSD 20        direct tissue tension or pressure on the sub-glans (high risk        area) or any other penile tissue areas. Long term PSD 20 use is        accomplished by the appropriate design characteristics in        addition to the proper selection of material, durometer,        thickness, shape, and mounting techniques. Having a thicker Main        Component and Internal Component, in addition to the possibility        of additional anchoring locations, will be important to        stabilize the penile shaft and prevent untoward pressure points        on the penile tissues.

Proximal Forces

-   -   The two primary areas where forces are exerted on the penile and        pubic tissues are at the distal and proximal ends of the PSD 20.        The proximal area of the penile shaft and pubic area can handle        a fair amount of force considering that the tissue makeup is        primarily ligamentous and bony. The distal area of the penile        shaft is the most fragile and sensitive area to be concerned        about. The PSD 20, without anchoring via sutures S, exerts high        force or tension directly on the distal sub-glans area. That is        why suture mounting of the PSD 20 is necessary to divert these        forces to the underlying very strong ligamentous Buck's and the        Tunica Albuginea penile shaft fascial tissues.    -   A patient having the PSD 20 implant in over time will result in        the penile shaft collagen and elastic fibers to stretch out,        resulting in less retraction or recoil forces. This is        favorable, especially at the distal shaft area. This collagen        and elastic fiber ‘stretch out’ is also favorable if the patient        wants to be “re-stretched” by removing the current PSD 20 and        placing a longer one in. This will result in more lengthening of        the erect penile shaft.

Distal Forces

-   -   There are two primary areas of concern regarding forces that are        exerted on the penile tissues, the proximal pubic and distal        sub-glans areas. The sub-glans area, located distally, is of        primary concern.    -   The sub-glans area requires the greatest protection. This area        is the primary source of irritation and pain if too much        pressure is exerted on this penile tissue over time. If any long        term, even minor force, is applied to this area, skin        irritation, pain, and even skin ulceration is possible.        Considering this, sutures are used to mount the distal area of        the device onto the very strong ligamentous type tissues of the        penile shaft, the Tunica Albuginea and Buck's Fascia. This        suture mounting prevents movement of the PSD 20 in a distal        direction, preventing PSD 20 pressure from being directly        transmitted onto the glans and sub-glans tissues. Anchoring        sutures are placed in the distal area of the PSD 20 and the        knots are placed, as previously specified, in direct contact        with Buck's Fascia BF, or placed on the outer surface of the IC        24 and under the outer layer of the MC 22. When force is placed        on PSD 20, either through intercourse, etc., the force exerted        onto the PSD 20 will be diverted and transmitted away from the        sub-glans area and to the mounting sutures. Then the stress or        force placed on the mounting suture will be transmitted onto the        strong ligamentous type fascia, the Tunica Albuginea TA.    -   It should be noted that knots are not sensed or felt by the        patient since they are not in direct contact with the penile        tissues.    -   In general, the PSD 20 is designed to distribute the forces in        the broadest fashion and to limit or eliminate the potential for        long term inflammation and trauma. It should be noted that these        are the main issues with prior art penile implants—high tissue        pressure irritation and pain in this sub-glans area, in addition        to skin ulceration and protrusion, which is causing many        patients to have it removed.    -   If anchored correctly and the proper PSD 20 size and shape is        selected, the long-term prognosis is favorable. Between mounting        the PSD 20 at the distal shaft area and eventually the penile        shaft collagen and elastin fiber stretching over time (which        would decrease penile recoil forces and PSD 20 pressures on the        penile tissues), this significantly helps reduce or eliminate        sub-glans area stress, irritation, and potential pain.

Inwardly-Directed Radial Forces, F_(RI)

-   -   PSD 20 inwardly-directed radial forces F_(RI) are kept at a        minimum. These forces play a moderate roll in stabilizing the        out-stretched flaccid or erect penile shaft; however, these        forces need to be kept at a minimum, so blood flow is not        constricted or limited during the erection process.    -   The MC 22 comprises a stretchable elastic silicone elastomer.        Placing the MC 22 on the penile shaft is similar to placing a        stocking on a leg. The MC 22, like a stocking, will exert a        minimal or very low inwardly-directed radial force, F_(RI). This        inwardly-directed radial force exerted from the MC 22 is        transmitted onto the penile shaft tissues, particularly Buck's        Fascia BF, Tunica Albuginea TA, Corpora Cavernosa CC, Corpora        Spongiosum CS, and associated nerves, blood, and lymphatic        vessels.    -   This inwardly-directed radial force F_(RI) is exerted during the        flaccid state and, more so, the erect state.    -   During the flaccid state, the MC 22 is designed to not exert        excessive inwardly-directed radial force F_(RI) and hinder or        prevent urine flow.    -   During the erect state, the MC 22 is designed to not exert        excessive force to prevent blood flow into the corpora tissues        during the process of erection in two primary ways: the first is        the S-Fold 951/950 pattern design found in the inner and outer        layers of the MC 22 (FIG. 2K). These folds 951 and 950 will        allow the beginning erect girth expansion to occur easily, and        with minimal inwardly-directed radial force F_(RI) by the simple        unfolding of the S-Fold 951/950. When the S-Folds 951/(50 have        completely unfolded, the silicone material of the MC 22, which        is elastic and very stretchy, will stretch out easily for the        balance of the erect girth increase until the full erection has        been achieved. The IC 24 does not play a significant role in        exerting inwardly-directed radial force since the IC 24 has a        C-shape and is not a complete tubular structure, like the MC 22.        Considering this, the IC 24 will simply “open up” during the        erection process. In addition, the IC 24 will have potential        outwardly-directed radial force to exert, so the IC 24 will        negate some of the inwardly-directed radial force exerted by the        MC 22.    -   During the erect state, and during the sex act inwardly-directed        radial forces F_(RI) are exerted. The PSD 20 may add some        additional inwardly-directed radial force F_(RI), and this force        will not be excessive as to increase the tension high enough to        push blood out (lose erection) during the sex act itself.    -   The PSD 20 exerts a minimal amount of this force, which not only        helps oppose the penile flaccid retraction force by its “grip”        on Bucks fascia/Tunica preventing its retraction, but also the        PSD 20 being a physical obstacle, being ‘seated’ in the pubic        pocket space and mounted at the penile distal end, in the path        of retraction and maintaining length as well.    -   There is a pressure differential that needs to be maintained.        The inwardly-directed radial force F_(RI) of the PSD 20 also        interacts with the outwardly-directed radial force F_(RO) from        the erection process. This becomes significant because a        pressure differential needs to exist, otherwise if the amount of        blood flow pressure needed to cause an erection is equal or        lesser than the inwardly-directed radial force exerted        externally from the device, the erection will not occur. In        addition, if the PSD inwardly-directed radial force F_(RI)        exerted is added to the external force of the sexual act, the        addition of both forces should not exceed the ability of the        penile tissues to retain the blood within the corpora. The        outwardly-directed radial force exerted by the IC 24, which will        counter and negate some of the inwardly-directed radial forces        of the MC 22, will provide the appropriate differential force        needed for the erection to occur.

Outwardly-Directed Radial Forces, F_(RO)

-   -   Outwardly-directed radial force F_(RO) is exerted by two        different mechanisms. The primary outwardly-directed radial        force is exerted by the blood flow entering into the penile        shaft during the erection process.    -   The outwardly-directed radial force F_(RO) exerted by this        erection blood flow must exceed the inwardly-directed radial        forces F_(RI) externally applied from the PSD 20 and the act of        sex itself. To achieve this differential in pressure, allowing        the outwardly-directed radial force F_(RO) not to be diminished        appreciably, two main factors are involved. First, the MC 22 is        unfoldable and stretchable, and exerts minimal inwardly-directed        radial forces F_(RI), and, secondly, the IC 24 is        “spring-loaded”, meaning that when the IC 24 is inserted into        the MC 22, which is shaped into a flat sheet, is bent or        partially closed first to then fit into the MC 22. This        “spring-loaded” mechanism allows the IC 24 to exert an        outwardly-directed radial force F_(RO) on the MC 22 thereby        countering and limiting the net inwardly-directed radial force        F_(RI) upon erection.    -   In addition, the MC 22 itself comprises one large pocket space        that extends proximally 22W, distally 22ID and laterally 22Q        (FIG. 2G) for the IC 24 to insert into. This pocket space holds        the IC 24 firmly onto the MC 22. The IC 24 provides additional        outwardly-directed radial expansion force allowing greater ease        of expansion under certain situations (some patients, for        example, may mount a weak erection so even moderate        inwardly-directed radial forces F_(RI) may thwart the erection        process).

Penile Human Anatomy, Physiology, and Safety Considerations andFlaccid-Erect States, and Posture in Relation to the PSD 20

The erect, and especially the flaccid penis, will bend, shorten,lengthen, twist and go through all those motions and in combination ofall those motions as well. The PSD 20 is designed with an elasticstretchy silicone material to bend, shorten, lengthen, twist, etc., to agreat degree, thereby accommodating for these motions. If a ridgeddevice, such as other patented devices, is placed, all of these motionswould cause moderate pressure points directly on the penile tissues. Itcan be appreciated trying to bend a flaccid penis with a hard-rigiddevice in place-this would cause the rigid device to dig into the peniletissues and cause irritation and pain.

The PSD 20 is designed with soft materials, rounded and tapered edges,flexible areas, etc., to avoid tissue injure and irritation. Duringnormal physical activity, such as squatting down or in a seatedposition, the penis alters its position due to its attachment to thepelvis pubic bone and ligaments. When the pelvis moves or rotates, thepenis moves as well. Considering that the PSD 20, which is now attachedby sutures to the penile fascia, will move with pelvic motion so it isimperative that the PSD 20 does not cause excessive stress or pressureon the penis, especially at the suture anchors at the distal portion ofthe penile shaft, or surrounding tissues during pelvic movement and thuspenile movement. For example, during a full squatting motion, the penispulls inward due to the pelvic rotation that occurs. If the penis pullsinward, then the PSD 20 pulls inward as well. The dorsal side of the PSD20 moves inward and in parallel step with the dorsal side of the penis,thereby avoiding pressure stress issues here. The ventral side of thePSD 20 moves inward (proximal) but has the potential to place stress onthe ventral surface of the penile shaft and other tissues if there is noaccommodation for this inward movement. Therefore, to avoid PSD 20proximal movement stress on the penile tissues, there will be severalsafety designs to prevent tissue injury. The first safety design will bethe rounded edges 22DT (FIG. 1N) of the proximal ventral end 22D of theMain Component. The rounded edges will promote a sliding motion alongthe tissues, instead of a sharp ‘digging’ in effect resulting inirritation and possibly pain. A second safety design is the MC proximallateral V-cut, 22O, will be placed in the proximal lateral area of theMC 22. An IC proximal lateral V-cut 24E, will parallel the 220, and willbe placed in the proximal lateral area of the IC 24. These V-cuts22O/24E will allow the proximal end of the PSD 20 to widen and allow fora dorsal-ventral expansion, or drop down, at its most proximal area.This allows tension relief and prevents excess pressures on penile andsurrounding tissues when the penis is moving in a proximal direction orin a dorsal bending position.

During ventral or downward bending motions the concave side of the penis(ventral side) will shorten and move the PSD 20 proximally. When the PSD20 moves proximally, it will slide as it moves, not tearing or grippingpenile tissues. In addition to the ventral side of the PSD 20 beingshorter in length to allow proximal movement without interfering orabutting up to tissues, the proximal area of the PSD 20 has a proximallateral V-cut 22O/24E that will allow this section to “drop down” in aventral direction if pressure is placed on the area. This V-cut areawill provide “give” to prevent unnecessary pressure to be exerted on theproximal edge of the PSD 20 and the penile tissues. Lastly, the PSD 20will shorten, to some degree, by material compression.

During dorsal or upward bending motions, the concave side of the penileshaft will shorten. Considering the PSD 20 on the dorsal surface extendsto the pubic pocket space 50 (FIG. 8E), the PSD 20 will not be able to“slide” in the proximal direction. Considering the PSD 20 is suturedinto place at the distal are of the penile shaft, the PSD 20 cannotslide distally. Since the PSD 20 is made of elastic materials it willshorten when compressed to some degree, and this will help will keepingpressure off if the distal suture anchor locations. In addition, the IC24 has a plurality of V-cuts 24H on the dorsal surface. When the penisbends in a dorsal or upward direction, the dorsal V-cuts 24H willapproximate, thereby shortening and not lengthening and thereby placingminimal to no pressure on the proximal pubic nor distal suture anchorlocations. During the dorsal bending the MC 22, which is made ofsilicone material that is very flexible and stretchy, will simplycompress and also lift upwards some, like bulging, to compensate for theshortening.

Elongation, by physical pulling whether in the penile flaccid or erectstate, will place minimal expected stress on the distal suture area ofthe penile tissues. Regarding the proximal area, and because the PSD 20is not permanently fixed or mounted at the proximal area, the PSD 20, ifpulled or elongated, will simply slide distally (and slightly out of thepubic pocket temporarily). Pushing down or shortening motions will causethe PSD 20 to compress, slide proximally on its ventral side, theproximal lateral V-cuts will widen, the MC 22 will buckle up a little,and the IC 24 plurality of V-cuts will approximate, and will preventexcessive pressure to be exerted on the distal suture anchor areas andpubic pocket area. In addition, the dorsal and ventral bending safetyfeatures will also assist in relieving stress or pressure withshortening motions. Twisting motions, which is a combination of theabove, will be accommodated by the aforementioned safety mechanisms.

PSD and Flaccid-Erect State Penile Position

The penis P normally hangs downward in the flaccid state, and thenprojects upward and outward in the erect state. Upon implanting the PSD20, the penis P will also tend to project downward in the flaccid state.The PSD 20 will, in addition, drop downwards with gravity, due to theweight of the device 20, and due to the proximal end flange 24D beingnon-tubular and allowing the main body of the PSD 20 to easily benddownwards. The PSD 20 (and penis P) can be moved upwards and downwardsif lifted with a hand for example with the easy bendability of the PSDproximal flange 22E. The PSD 20, to some degree, might not entirely dropfully in a downward position but outwards due to the scrotal positionrelative to the penile shaft, and the length of the penile shaft itself.The scrotum may contract inwards towards the body, and actually provide“lift” to the penile shaft PS, thus elevating it in a more upwardposition. The shorter the penile shaft PS the more elevated inappearance it will naturally be. This elevation, due to the scrotalcontraction and/or very short penile retraction state, will lift thepenile shaft PS with or without a PSD 20 implanted, so the upwardprojection of the penis P would be its natural position regardless.

PSD and Pressure on Penile Sub-Glans Area

The PSD 20 exerts an inwardly-directed radial “gripping” force to thepenile tissues helping to stabilize the extended penile shaft PS. Eventhough the PSD 20 is suture mounted distally and abuts at its proximalend to the pubic bone and ligaments, this inwardly-directed radial“gripping” force, holds the tissue, to some degree, and helps preventthe recoiling or retraction forces of the collagen, elastin, and musclefibers.

These collagen, elastic, and muscle fibers exert not only an inward“collapsing” force, but also a “pulling” force, in a distal to proximaldirection. During the flaccid state this force results in a shorteneddeflated shrunken penis P in length and girth. These fibers exert anappreciable inward “collapsing” force, also called inwardly-directedradial force F_(RI), and this is evident in the flaccid state of thepenis P being retracted (shortened) and losing girth (deflated or“collapsed”).

Upon physical stretch of the flaccid penile tissues, the linear recoilor retraction forces opposing this stretch are maximal. These linearrecoil forces are countered primarily by the distal suture mounting ofthe PSD 20, the proximal abutment of the PSD 20 by the pubic bone andligament area, and the little gripping effect of the PSD 20 materialdirectly contacting the penile tissues. All of these “anti-recoil”factors maintain the PSD 20 in the most favorable (lengthened) position.

These anti-penile retraction elements, opposing the proximally directedlinear retraction forces of the penis P, help re-direct these opposingproximally directed linear forces away from the glans and sub-glans areaand onto the distal fascial tissues (via suture mounting), such asBuck's BF and the Tunica Albuginea TA fascial elements, in addition tothe pubic bone and ligamentous area (via abutment of PSD 20). The PSD 20is designed to redirect and eliminate, or at least minimize all forcesdirected onto the Glans and sub-glans area of the penis in order toavoid, as discussed previously, the sub-glans tenderness and pain thathas been observed with patients using prior art penile implants.

PSD and Urethral Tension

The PSD 20 is designed to avoid exerting direct or indirect pressure onthe urethral area (U). If pressure is exerted in this area, a turbulenturinary flow may result and cause tissue irritation. As mentionedpreviously, a U-shaped mold design 22R for the MC 22 is employed to takeall pressure off the urethra area U in the flaccid and erect states.Considering that the IC 24 is open on its ventral side, there is nocontact on the urethral area and therefore requires no modifications.(FIGS. 9B-9C).

PSD and Erection Blood Flow Pressure Differential

The PSD 20 is placed directly on the penile shaft tissues, includingBuck's Fascia BF and the Tunica Albuginea TA. The PSD 20 exerts alimited or minimal inwardly-directed radial force F_(RI) eliminating orminimizing impeding the erection blood flow process.

When a normal erection takes place, blood flows into the corporacavernosa CC and the corpora spongiosum CS with minimal opposing forcessuch as the retraction/recoil forces/pressure from the penile structuraltissues themselves such as the collagen, elastin, and muscle cellfibers. The blood flow causing the erection must enter into thecavernosal tissues with a fair amount of (normal) pressure to overcomenot only the normal retraction forces of the penile tissues but alsofill the penis in its entirety, filled to capacity resulting in a veryfirm “hard” feel. When the PSD 20 is implanted, there is a small amountof inward pressure or inwardly-directed radial force F_(RI) exerted whenthe erection blood flow process occurs. This minimal amount of pressureincrease will not impede the erection process. The PSD 20 is designed tohave four elements to limit this amount of pressure; the S-Fold 951/950in the inner and outer layers 22S1/22T1 of the MC 22; the very highstretch-ability of the silicone material itself; and the F_(RO) exertedby the IC 24; and the outstretched position of the penile tissues whicheliminates the contracting forces of the collagen, elastic, and musclefibers that would normally be encountered during an erection process.These four factors will minimize the forces opposing the erectionprocess.

The S-Fold 951/950 in the inner and outer layers 22S1/22T1 of the MC 22will simply unfold when the penile pressure from the erection processincreases. When the penile erection process continues, the S-Folds951/950 will completely unfold, but will only allow for an erect girthexpansion of 1-1.5 inches. Now, when the erect penis P continues toincrease in its girth size, the second element, PSD 20 stretchability,will now allow the rest of the erect girth circumference to be realized.The third element helping reduce the F_(RI) issue, is the assistance ofthe F_(RO) of the IC 24. This F_(RO) had been helping with the processof limiting the F_(RI) throughout the erection girth expansion process.Note that the outer layer 22T1 of the MC 22 will contain about 50%(maybe place a range of 10-90%) less S-Fold 950 than the inner layer951. The MC 22 is designed to exert minimal F_(RO) on the flaccidtissues, so when the erection process occurs the MC 22 stretches outeasily due to the unfolding of the S-Folds 951/950 found in both innerand outer layers 22S1/22T1 and stretching of the very stretchablesilicone elastomer used. The IC 24, which is spring-loaded to exert aF_(RO) immediately upon placement, provides some assistance to theF_(RO) exerted by the erection process. In addition, the IC 24 is openon the ventral end which allows the IC 24 to open more freely. (FIGS.3A-3B).

PSD and Excessive External Forces

There are many different (natural) circumstances by which externalforces, other than those exerted by the PSD 20, are applied to thepenile shaft. For example, many scenarios exist such as placing thepenis in tight underwear, fondling during the erect/flaccid states,bending, pulling, downward pushing, masturbation, sexual act, etc. ThePSD 20 is designed to “give”, “buckle”, and bend, while anchored andstable under such circumstances.

Dorsal Bend

When the penis P is bent in a dorsal (upward) direction, the penileshaft skin and fascia “shorten” on the dorsal (concave) side andlengthen on the ventral (convex) side. The PSD 20 adjusts by shortening;the IC plurality of V-cuts 24H approximating, and some minor upwardcompression and buckling of the softer Main Component 22 siliconematerial. This adjustment eliminates generating significant pressure orforces on the proximal pubic area abutment space and the suture mountedpenile tissues at the distal penile area. If these counteranti-pressure/force elements of the PSD 20 design were not in place,then there would be too much force exerted onto the distal suture anchorpoints, and subsequently the glans and sub-glans areas, and the proximalpubic abutment area or pubic pocket space 50. Stress relief isaccomplished by shortening the length of the IC 24 via the plurality ofdorsal V-cuts 24H. See FIGS. 3 and 9-9A. Thus, when dorsal bendingoccurs, the V-cuts 24H collapse (see FIG. 9), thereby permitting the IC24 to bend without causing the proximal end flange 24D to displacefurther within the pocket 22Q of the MC 22, and subsequently pushing thedevice further into the pubic pocket space 50 and tissues. In addition,a structural design including an accordion type buckling zone 22L of thedorsal proximal area of the MC 22 (as well as a corresponding bucklingzone 24F of the IC 24) ensures that when the penis P is bent in a dorsalupward direction, the shortening of the penile dorsal skin and fasciacoincide with a parallel shortening of the PSD 20. The proximal area ofthe MC 22, and the IC 24, are manufactured in a slightly wavy fashion(e.g., buckling spaces 22L and 24F, respectively) so that when excessiveforce is exerted, the MC/IC 22/24 bend or bow and the slightly wavyareas 22L/24F becomes wavier (the peak and trough depths of the wavesincrease). This design provides the “give” and relieves stress with thisdorsal bend situation. It should be further noted that the MC 22,considering its very stretchable material, collapses upon itself whencompressed or when force is exerted, so a wavy design may not benecessary. This feature helps in preventing excessive forces exerted onthe penile tissue.

Ventral or Lateral Penile Bending

A wave “buckle” design may not be required on the lateral or ventralportions of the MC 22 because these areas do not directly abut up to anystructures, so the MC 22 freely “slides down” the penile shaft PS tocompensate for the decreased length of the ventral downward bent penilesurface. However, when the PSD 20 slides down, it may exert pressure onthe urethra U and or other tissue components in the area. The PSD 20design takes into account the penile ventral anatomy and the ventraldownward bending of the penile shaft and the posterior movement of thePSD 20. A wave might be considered, or a built-in joint, such as theproposed proximal lateral V-cut 220, which can be made on both of thePSDs' MC/IC 22/24. There will be a proximal lateral V-cut 220 on bothlateral sides of the MC 22. There will be a proximal lateral V-cut 24Eon both lateral sides of the IC 24, so when the PSD 20 moves in aposterior direction (like in a ventral bend) the PSD 20 will not onlyslide proximally, but “gives” at the built-in joint area allowing thePSD 20 to widen or open up. This opening or inferior drop relieves thestress placed on the ventral penile elements such as the urethra. Inaddition, stress relief is accomplished when the ventral length of theIC 24 is shortened, using a plurality of ventral V-cuts 24I (if needed),similar to the plurality of dorsal V-cuts 24H (if needed). Thus, whenventral bending occurs, the IC 24 plurality of ventral V-cuts 24Icollapse or approximate to one another, thereby preventing furtherproximal ventral displacement or proximal movement and thus preventingtissue pressure and stress.

The Act of Intercourse or Masturbation—Penile Push Pull forces

All modifications to anchor and stabilize the PSD 20 greatly assist instabilizing the PSD 20 and preventing tissue stress points. To addadditional assistance to increase force distribution, patients areinstructed to use oil lubrication (S-Lube) during intercourse ormasturbation. The lubrication, with the sliding motion of the hand orvaginal/anal tissues across its surfaces, transmits the pressure moreevenly, with less drag or pull on the penile skin tissues, and thereforeless transmission of forces onto the PSD 20 and subsequently onto thepenile suture mount area and pubic bone and ligament areas. So, thissliding on the penile skin throughout the penile shaft prevents orsignificantly reduces excessive pinpoint force distribution (or drag onthe skin and thus the PSD 20 and penile tissues) onto the distal,mid-shaft, and proximal shaft areas. Avoidance of this pinpoint force iscritical, especially in the distal sub-glans area where the anchoring islocated.

PSD and Penile Implant PSD and Penile Foreign Body Reaction

Upon placement of the PSD 20, the body immediately responds to thisimplant as an “enemy”, or a foreign body. This response by the body tothis ‘foreign body; is called a Foreign Body Reaction FBR. Consideringthe size and material makeup of the PSD 20, the body treats this implantas a foreign body, and thus, a Foreign Body Reaction FBR via the immunesystem takes place. This type of FBR reaction is common with implants,including Breast Implants, Knee and Hip Implants, etc.

The body, or immune system, encounters a foreign body or implant device,it will first need to determine if this foreign substance isdissolvable, engulf-able, or surround-able. If the device is notdissolvable or engulf-able, then the body mounts a foreign body reactionthat surrounds it with collagen. This FBR that surrounds the foreignbody is essentially entombing or encapsulating it and protecting thebody from contact with it.

A FBR is desirable in this circumstance. The immune system “sees” thisPSD 20, determines it is “foreign” and reacts by developing a collagensheet enveloping the PSD 20 in its entirety, “entombing” it in acollagen sheet or envelop. This collagen layer developed by the immunesystem will prove to be beneficial providing a buffer space or anotherlayer between the PSD 20 and the surrounding tissues, and thereforeresult in the PSD 20 not touching the penile tissues directly. This willprovide another layer of cushion and protection from irritation as well.The new collagen formation, via the FBR, provides some stabilization ofthe PSD 20. Another advantage of the PSD 20 being entombed within thiscollagen envelope is that this protects the PSD 20 against long termdegradation attempts from immune system exposure and chemical breakdown,and thereby provides longevity of the product.

PSD and Penile Ventral Area

Alternative designs of the PSD 20 are available to match the clinicalsituation presented.

For example, the PSD 20 may comprise the same length throughout, with noproximal end flange 22E and 24D. This will result in the PSD 20 have thesame length on its dorsal and ventral sides. The reason for this is thatthe pubic pocket space 50 (space by the pubic bone and ligament area)may not exist, in a substantial manner, in some patients. In this case,the dorsal and ventral lengths will be the same. The PSD 20 can beeither manufactured without the proximal end flanges 22E/24D or they canbe “cut-to-fit” as well.

Since there is space in the pubic bone and ligament area 50, the lengthof the PSD 20 on its ventral side will, in the vast majority of cases,be shorter in length than the length of the dorsal side of the PSD 20.In addition, the shortened length of the ventral side of the PSD 20 withthe proximal lateral V-cut 220, will also accommodate for the proximalmovement of the penile shaft during squatting motions. The reason forthis design is because the ventral area of the penile shaft, involvingthe urethra and scrotal tissues, anatomically moves proximally when aperson squats down (or if the penis P is bend in a downward fashion),and the penis P is drawn into the body. This occurs because the penileshaft PS is attached to the pelvic/pubic bone and ligaments, so when theperson squats down the pubic bone rotates and pulls the penis P into thebody. When this occurs, the PSD 20 will also be pulled into the body aswell considering that the PSD 20 is attached with sutures at the distalarea. Now, if the PSD 20 is the full length of the penile erect lengthand the person tries to squat down, the penis P and the PSD 20 move intothe body, but the problem here is that with ventral proximal motion ofthe PSD 20 into this area, the PSD 20 may “dig into” the urethral andscrotal areas of the penile shaft PS, thereby resulting in temporarypressure/irritation there. Even though the PSD 20 is designed to besmooth with rounded edges in all appropriate places which will allow forthe PSD 20 to slide along the penile tissues, another safety mechanism,the proximal lateral V-cut 220 will allow for additional or unexpectedmovement of the device in case there was additional tension or pressurein that area. Considering this, the ventral side of the PSD 20 is thusmade shorter in length, will be smooth with round edges, and will have alarge proximal lateral side V-cut 220 to allow a ventral drop down ofthe ventral portion of the device 20 to relieve pressure on proximalventral tissues. In addition, the plurality of V-cuts on the IC 24ventral surface 24I (if needed), which will parallel the plurality ofdorsal V-cuts 24H, will allow for the ventral surface of the PSD 20 tocollapse closed during ventral bending thus preventing elongation of thedevice into sensitive urethral and scrotal tissues proximally.

PSD and Uncircumcised Patients

It is always recommended to be circumcised prior to any procedureinvolving male enhancement, which would include PSD 20 insertion, fillertreatment, etc. The reason for this is that the foreskin, oruncircumscribed skin, is very thin and fragile. The PSD 20, or anyimplantable subcutaneous device may have the potential to irritate thisthin skin over time. In addition, permanent filler cannot be injected,with substantial quantities, into this thin skin which results in anarrower asymmetrical and imbalanced distal penile shaft. If a patientrefuses to get circumcised there is a low risk option available. If thepatient desires to just have a PSD 20 placed, and not have acircumcision, then there is no issue except for a small risk of skinirritation by the foreskin area. However, if the patient wants a PSD 20and filler treatment, then a custom PSD 20 can be designed to be thickerat the distal end to compensate for having no, or little, filler placedthere.

For example, assume the patient is 2 inches in flaccid length, 3.5inches in flaccid girth, 6-inches in erect length, and 4.5 inches inerect girth. His desire is to optimize his flaccid length and achieve a7-inch erect circumference/girth. The patient then has the PSD inserted,which now yields a 6-inch flaccid length, 5-inch flaccid girth, 6-incherect length, and a 6-inch erect girth. Considering that the fillertreatment is next, to now increase the erect girth the additional inchdesired, the filler will now be placed in the penile shaft, but littlewill be placed in the distal shaft “foreskin” area F of the penileshaft. The 7-inch girth goal will be reached in the proximal andmid-shaft regions, but not at the distal foreskin F location. Thisevidently will result in a possible girth imbalance if the foreskin areaF does not accept a reasonable amount of filler. In this case where thefiller cannot provide the girth gains at the distal portion of thepenile shaft, the PSD 20 can be designed to be thicker in that distalregion either by directly adding a SIC 24J for that space, or have acustom designed PSD 20 made, with a thicker distal end to compensate forthe lack of filler placed in the distal shaft foreskin area. Eithersolution will achieve a much better balance. So the PSD 20, not thefiller treatment, can thus provide the lack of girth at that distalshaft location. After PSD 20 placement, the proximal and mid-shaft willbe 6 inches in circumference, and the distal shaft will be 7 inches.Then, after two or three filler treatments, the proximal and mid-shaftflaccid girth will reach the 7-inch size now matching the distal 7-inchgirth provided by the PSD. A filler “transition” zone FTZ, will becreated between the larger PSD distal end (being 7-inches in girth) andthe smaller portion approximating (which is 6-inches in girth). Toaddress this filler transition zone FTZ, filler will be placed in thisarea to provide an appropriate transition (from skin with filler to skinwith just the PSD 20 under it) into the distal shaft area in order toprovide a “feels natural” experience.

PSD Delivery Devices

The PSD 20 is delivered to the subcutaneous penile shaft subcutaneousspace SS (FIG. 7B) via delivery devices. The delivery devices comprisetwo components; the Glans Gripper Device 28 (FIGS. 5-5A) and theT-Device 30 (FIGS. 4-4B). The Glans Gripper Device 28 is designed to beplaced the PSD's tubular tunnel TT (FIGS. 1, 1J and 7B), then gentlygrip the glans, and with gently pulling motion of the Glans GripperDevice 28 and a pushing motion of the PSD 20, the PSD 20 will slide overthe glans and into the subcutaneous space SS of the penile shaft PS. TheT-Device 30 is used to assist in the pushing proximal motion of the PSD20. The T-Device 30 will insert itself into a proximal dorsal receptionslit 24K (FIG. 4B) of the IC 24. The T-Device 30 will gain access toslit 24K by being placed through the dorsal mid-line slit 22J of the MC22. The objective of these delivery devices is to deliver the PSD 20into the penile subcutaneous area SS, then be pulled out, leaving thePSD 20 in place. The Glans Gripper Device 28 comprises a distal end 28A,a medial portion 28B and a proximal end 28C comprising finger grips. Theworking distal end 28A comprises respective pads 28D on each tine of thedistal end 28A.

It is preferred that the PSD internal surface 22S2 and external surface22T3 (FIG. 1H) be lubricated with a biodegradable sterileCarboxymethylcellulose Gel Lubrication (C-Lube) to assist in sliding thePSD 20 into the subcutaneous space SS and onto the penile fascia tissue(PF) and penile skin underside (PSU) The C-Lube is a safe non-irritatingCarboxymethylcellulose gel, or other very viable substitutes such ashyaluronic acid gel, or certain non-irritation and easily digestibleoil.

Furthermore, it should be noted that when the PSD is implanted, theforeign body reaction FBR will surround the PSD 20 with a collagenlayer. This layer entombs the PSD 20 making it unseen or invisible tothe immune system.

The IC 24 and MC 22 will need to slide on one another if a plurality ofV-cuts and/on the dorsal and/or ventral sides (24H and 24I) are toapproximate, edge to edge (24HE/24IE, respectively). When the penis Pbends, the plurality of V-cuts will approximate, thus moving or slidingwithin the MC pocket space 22I. Silicone rubber materials sliding oneach other may result in friction, and thereby result in wear and tearon the IC 24 and MC 22. To help prevent this, Sterile Medical GradeSilicone Oil (S-Lube) may be used to lubricate the pocket space 22I ofthe MC 22 to allow for the IC 24 to slide on the MC 22 while the V-cutsedges are approximating or are in a sliding motion. Theoretically, if alubricant such as Silicone Oil is used, it may need to be replenishedover time. There is a potential pathway for the oil to migrate out ofthe dorsal mid-line slit 22J of the MC 22 and into FBR capsule space(FBCS). If this is the case, there is one solution that will help tomaintain the presence of S-Lube within the pocket 22I are of the MC 22,and that is to periodically (e.g., every 2 years, etc.) re-inject withS-Lube in the implanted PSD 20, i.e., inject within the pocket space 22Iof the MC 22.

Main Component Dorsal Mid-Line Slit 22J

The MC dorsal mid-line slit 22J will need to be designed to help preventleaking of the S-Lube into the pocket space 22I. This will be done bymaking the edges of 22J into a tongue 22JT and groove 22JG pattern (seeFIG. 2A) whereby they will fit together in this fashion. It should benoted that at each end of the dorsal mid-line slit 22J is a tearreduction aperture 22H to minimize any possible tearing of the adjacentMC outer layer 22T1 during opening of the slit 22J.

PSD Delivery Technique (DT)

The PSD 20 is delivered into the penile subcutaneous space via theDelivery Technique (DT). The PSD 20 is first lubricated with C-Lube onits external and internal surfaces 22T3 and 22S2 (FIG. 1H) of the PSD20. The user grips the T-Device 30 via a handle portion 30A and insertsa curved working distal end 30B through the dorsal midline slit 22J ofthe MC 22 and slides the distal end 30 along the dorsal side of the IC24 until the distal end 30B is engaged within the IC receiving slit 24K.Once in place, the Glans Gripper Device 28 is placed through the PSDtubular tunnel TT (FIG. 7B) and grips the glans G using respective pads28D (e.g., silicone mitts) on the working distal end 28A. Then, with acareful forward motion of the PSD 20, the T-Device 30 is pushedproximally while pulling the Glans (G) simultaneously with the GlansGripper Device 28, the PSD 20 will slide into position onto thesubcutaneous space SS of the penile shaft.

The DT, using the Glans Gripper Device 28 and the T-Device 30 fordelivering the PSD 20 is depicted in FIGS. 7-8 and comprises thefollowing steps:

-   1. The patient is prepared in a sterile fashion.-   2. The patient is provided with topical and local anesthesia.-   3. A superficial incision is made along the existing circumcision    line (FIG. 7), such that the penile skin PSK can be displaced to    reveal the subcutaneous space SS of a patient's penis (FIG. 7). By    opening this existing circumcision scar CircS, there are no    additional scars formed. Note: if the patient is not circumcised,    then a circumcision line will be made, and as distal as possible on    the penile skin sub-glans area SGA.-   4. Fascial plane FP dissection (FIG. 7A) takes place using blunt    instruments. This makes a clear unobstructed path for PSD 20    placement just on top of Buck's Fascia BF and all the way into the    pubic pocket 50. All blunt dissection is above Buck's Fascia BF.-   5. Frequent lavage is performed with sterile saline and antibiotics.-   6. Length and girth measurements are taken for the PSD 20 in flaccid    and in induced erect states (saline injection into corpora cavernosa    CC), as discussed previously. Dorsal and ventral sides of the penile    shaft PS are measured from the proximal end, all the way to the    sub-glans area. In addition, depending on the goals, an outstretched    flaccid length is also taken. It is important to measure the true    erect length (for an optimal flaccid PSD 20), and an outstretched    flaccid length (for an optimal erect PSD 20 and Supra-optimal    flaccid lengthening).-   7. Once the size of the PSD 20 has been determined, the correct size    PSD 20 can be selected.-   8. The PSD 20 is first lubricated on its external 22T3 and internal    22S2 surfaces (FIG. 1H) with C-Lube or similar biodegradable    dissolvable lubricant. The pocket space 22i of the MC 22 is    lubricated with S-Lube.-   9. The T-Device 30 is then inserted (FIG. 4B) through the dorsal    midline slit opening 22J of the MC 22 and positioned onto the IC    T-Device reception slit 24K (FIG. 4B).-   10. Once the T-Device 30 is in place, the Glans Gripper Device 28 is    placed through the PSD tubular tunnel TT and grips the glans G, as    shown in FIG. 7B.-   11. Then, with a careful forward motion of the PSD 20, pushing with    the T-Device 30 and pulling the Glans G simultaneously, the PSD 20    will slide into position onto the penile tissue and under the penile    skin PSK.-   12. Markings will be made on the penile tissue using a medical    non-toxic pen. The pen will be placed through the suture slits    22N/24G (FIG. 7C) to make the pen markings directly onto the penile    tissue to exactly correspond to where the suture slits are.-   13. After the pen markings are made, the distal end 22A of the PSD    20 will be folded over, like cuffing a shirt sleeve, to expose the    distal penile tissue and the pen marking locations.-   13. Sutures will then be placed into the Tunica at those pen marked    areas.-   14. Then the suture ends will be threaded through the PSD dorsal    surface suture slits 22N/24G to come out of the corresponding suture    slits on the PSD's ventral surface.-   15. Then the distal end 22A of the PSD 20 will be folded back into    position.-   16. Then the sutures will be pulled through 22N/24G completely, and    then knots will be made (FIG. 2E). It should be noted that the    S-Clip 80 will need to be in place before the knots are placed.-   15. Pressure and length measurements are taken while the PSD 20 is    in place. An erect state will be induced (saline injection into    corpora cavernosa CC). The pressure is measured to determine the    differential between the erect pressure prior to PSD 20 placement.    Erect state observations take place, with special attention to erect    length, erect girth, PSD 20 shape, distal tension, etc.-   16. Final lavage with sterile saline and possible antibiotics.-   17. External sutures ES are placed to close the circumcision line,    as shown in FIG. 8. Suture removal, if non-absorbable sutures were    used, will take place on day 14.-   18. No intercourse until day 30.

19. Subsequent permanent filler treatment 26 (FIG. 8A) in 30 days.

PSD: Removal and Re-Insertion

Considering that the PSD 20 is placed in a permanent secured fashionunder the penile shaft skin PSK, even though it can be removed at anytime placed, long term stretching of the penile tissues will occur andsubsequent restretching at a later point in time will be possible. Thiswill subsequent penile tissue stretching will allow for additionalpenile flaccid and/or erect length by placing a longer PSD 20. Forexample, when the PSD 20 is placed into position, it not only exerts aforce and prevents the penile shaft from retracting when in its flaccid(and erect) state, but it also causes penile tissue changes resulting ina “stretch effect”. This constant applied force ultimately stretches-outthe penile shaft PS resulting in lengthening in the flaccid and erectstates. Then, after the penis P has stretched out and the applied forcefrom the PSD 20 has reduced, the PSD 20 can be removed and a new andlonger PSD 20 can be placed in and now apply a “new” force, again, tore-stretch the penile shaft PS to new and greater lengths. The removalof the PSD 20 involves a sterile technique, opening the circumcisionline, anchor suture removal, and then sliding the PSD 20 out. Then a newPSD 20 can be inserted, if the patient desires additional lengthening.Considering the penile tissues have had time to stretch, a new PSD 20can be placed to “re-stretch” the tissues even further to obtainadditional erect lengthening.

PSD: Selection Guidelines: Some Clinical Examples

-   Patient #1: Desires sub-optimal increase in flaccid length only    -   Patient Info    -   46-year-old white healthy circumcised male with normal penis.    -   Erect Dimensions: 6-inches in length, 4.75-inches in girth    -   Flaccid Dimensions: 2-inches in flaccid length, 3.75-inches in        girth    -   Patient Desires: Flaccid length increase to 5-inches, no change        in girth.    -   Tx: PSD S-Fold 20A without PE (no proximal end flanges 22E/24).        PSD 20A will be 5-inches in length.    -   Insertion Technique: Standard circumcised line entry, blunt        dissection with measurements, device placement on out-stretched        penile shaft and PSD 20A mounted on 1.5 inches of stretched out        penile shaft which would equal 4.5 inches. Then, post placement,        the PSD 20A will occupy 4.5 inches of the flaccid stretched        penile shaft, while the remaining ½ inch will remain ½ inch.    -   Sutures placed at distal and proximal locations to stabilize the        PSD 20A.-   Patient #2: Desires optimal increase in flaccid length only.    -   Patient Info    -   32-year-old white healthy circumcised male with normal penis.    -   Erect Dimensions: 7-inches in length, 4.5-inches in girth    -   Flaccid Dimensions: 3-inches in flaccid length, 3.5-inches in        girth    -   Patient Desires: Flaccid maximal length increase to 7-inches, no        change in girth.    -   Tx: PSD S-Fold 20A 7-inches in length.    -   Insertion Technique: Standard circumcised line entry, blunt        dissection with measurements, device placement on out-stretched        penile shaft and PSD 20A mounted stretched out penile shaft to        optimal length of 7-inches,    -   Sutures placed at distal location to stabilize the PSD 20A.-   Patient #3: Desires Increase in Erect length    -   Patient Info    -   58-year-old black healthy circumcised male with normal penis.    -   Erect Dimensions: 7-inches in length, 5-inches in girth    -   Flaccid Dimensions: 4-inches in flaccid length, 4-inches in        girth    -   Patient Desires: Optimal erect length increase, no change in        girth.    -   Tx: PSD S-Fold 20A: If optimal stretch is 8-inches, then an        8-inch length device is placed. Both components provide for        structural support. The Internal Component, which may need to be        thicker due to the retraction forces presence, adds physical        support against the retraction force and assists in the “firm”        feel of an erection.    -   Sutures placed at distal location to stabilize the PSD 20A.-   Patient #4: Desires Optimal increase in Girth Only    -   Patient Info    -   21-year-old white healthy circumcised male with normal penis.    -   Erect Dimensions: 5-inches in length, 4.75-inches in girth    -   Flaccid Dimensions: 2-inches in flaccid length, 3.75-inches in        girth    -   Patient Desires: Girth increase to 6.5-inches, no change in        length, no insert device desired. Not concerned with flaccid        retracted look post filler tx.    -   Tx: Filler treatment only.    -   Injection Technique: Standard Protocol.-   Patient #5: Desires Optimal increase in Girth and Optimal Flaccid    Length    -   Patient Info    -   28-year-old white healthy circumcised male with normal penis.    -   Erect Dimensions: 5.5-inches in length, 4.5-inches in girth    -   Flaccid Dimensions: 2.5-inches in flaccid length, 3.5-inches in        girth    -   Patient Desires: Girth increase to 6.5-inches, optimal flaccid        length.    -   Tx: PSD S-Fold 20A 5.5 inches in length, and permanent filler        treatments.    -   Injection Technique: Standard Protocol of 2-3 treatments of        filler treatments to reach 6.5-inch girth. Note: If a larger        Main Component is inserted with Internal Component for firm        feel, then maybe can accomplish some additional girth, and        reduce the filler treatment to two sessions.    -   PSD Insertion Technique: Standard circumcised line entry, blunt        dissection with measurements, device placement on out-stretched        penile shaft and PSD 20 mounted on 1.5 inches of stretched out        penile shaft which would equal 4.5 inches. Then, post placement,        the PSD 20 will occupy 4.5 inches of the flaccid stretched        penile shaft, while the remaining ½ inch will remain ½ inch.    -   Sutures placed at distal and proximal locations to stabilize the        PSD 20.-   Patient #6: Desires Optimal increase in Girth and Optimal Erect    Length    -   Patient Info    -   60-year-old Spanish healthy circumcised male with normal penis.    -   Erect Dimensions: 5-inches in length, 4.5-inches in girth    -   Flaccid Dimensions: 2-inches in flaccid length, 3.5-inches in        girth    -   Patient Desires: Girth increase to 6.5-inches, optimal Erect        length.    -   Tx: PSD S-Fold 20A: If max stretch out is 6.5-inches, then a        6.5-inch length PSD device is placed. Note: A thicker Main        Component may be considered to assist in girth; this limits        filler treatments needed. There might be a possibility to        provide the entire length and girth with the Main Component and        Internal Component.    -   Injection Technique: Standard Protocol of 2-3 treatments to        reach 6.5-inch girth.    -   PSD Insertion Technique: Standard circumcised line entry, blunt        dissection with measurements, device placement on out-stretched        penile shaft and PSD 20 mounted on 1.5 inches of stretched out        penile shaft which would equal 4.5 inches. Then, post placement,        the PSD 20 will occupy 4.5 inches of the flaccid stretched        penile shaft, while the remaining ½ inch will remain ½ inch.    -   Sutures placed at distal and proximal locations to stabilize the        PSD 20.-   Patient #7: Pt with existing PSD 20 desires to increase length of    the erect state    -   Patient Info    -   22-year-old white healthy circumcised male with normal penis.    -   First PSD 20 placed in 12 months ago and insertion procedure        uneventful        -   Original Erect Dimensions: 6-inches in length, 4.5-inches in            girth        -   Original Flaccid Dimensions: 2-inches in flaccid length,            3.5-inches in girth        -   Post PSD insertion Erect Dimensions: 7-inches in length,            5.5-inches in girth        -   Post PSD insertion Flaccid Dimensions: 7-inches in length,            5.25-inches in girth    -   Patient Desires: Length increase to 7.5-8 inches. Girth increase        to 6.5-inches, optimal Erect length desired on second PSD 20        placement.    -   Tx: Second PSD S-Fold 20A: Max stretch is 8-inches, then an        8-inch length device is placed. Both components will be higher        in durometer and thickness for structural support of a now        lengthy penile shaft. The Main Component provides most of the        counter force of the penile retraction and is thicker to do this        and provide for the girth increase. The Internal Component is of        higher in durometer and thicker for support and provide some        girth increase. The Internal Component adds physical support        against the retraction force and assists in the “firm” feel of        an erection as well. Note: Combination filler treatment will be        recommended to not only achieve the girth size, but also to        thicken the skin of the penile shaft to provide support and a        more natural palpable feel of the PSD 20.    -   Injection Technique: Standard Protocol of 2-3 treatments to        reach 6.5-inch girth.    -   PSD Insertion Technique: Standard circumcised line entry, blunt        dissection with measurements, device placement on out-stretched        penile shaft and PSD 20 mounted on 1.5 inches of stretched out        penile shaft which would equal 4.5 inches. Then, post placement,        the PSD 20 will occupy 4.5 inches of the flaccid stretched        penile shaft, while the remaining ½ inch will remain ½ inch.    -   Sutures placed at distal and proximal locations to stabilize the        PSD 20.-   Patient #8: Uncircumcised Patient Desires Optimal Erect Length and    Girth    -   Patient Info    -   29-year-old Black healthy uncircumcised male with normal penis.    -   Measurements:        -   Erect Dimensions: 6-inches in length, 4.5-inches in girth        -   Flaccid Dimensions: 2-inches in flaccid length, 3.5-inches            in girth        -   Goal Post PSD insertion Erect Dimensions: 7-inches in            length, 7-inches in girth        -   Goal Post PSD insertion Flaccid Dimensions: 7-inches in            length, 6.5-inches in girth    -   Patient Desires: Optimal Erect Length increase to 7-inches.        Girth increase to 7-inches.    -   Tx Note: Special consideration of PSD 20 design considering the        Pt does not want to be circumcised. The PSD 20 is modified        distally or expanded to a 7-inch (total) circumference.    -   Tx: PSD S-Fold: Hyper-stretched flaccid length is 7-inches, then        a 7-inch length device is placed. Both MC 22/IC 24 of the PSD 20        will be higher in durometer and thickness for structural support        of a now lengthy penile shaft. The MC 22 provides some of the        counter force of the penile retraction and is thicker, providing        for the girth increase. The IC 24 is higher in durometer        providing most of the counter force of the penile retraction,        and thicker to provide some girth increase. The IC 24 adds        physical support against the retraction force and assists in the        “firm” feel of an erection as well. Note: Combination filler        treatment is recommended to not only achieve the girth size, but        also to thicken the skin of the penile shaft to provide support        and a more natural palpable feel of the PSD 24. Very little        filler is placed distally, but just tapers to keep a natural        transition from filler to PSD 20 in foreskin area.

It should be understood that the placement of the PSD 20 can besupplemented with the use of permanent silicone oil filler treatments toreach desired girth goals. In addition, such treatments can assist inconcealing the PSD 20 (e.g., the patient may be able to feel edges ofthe implanted PSD 20). Alternatively, placement of the PSD 20 alone maybe sufficient to the patient in achieving the girth and flaccid-erectlength size desired.

Erectile Dysfunction (ED) Support

The PSD 20 may provide Erectile Dysfunction (ED) support. For example,if a patient cannot achieve a very firm erection, the PSD 20 may providestructural support, from the harder IC 24, thus providing the additionalfirmness desired. On the other extreme, if a patient cannot have anerection normally, even with medical treatment, and opts not to have apenile balloon implant or metal rod implants placed, then a PSD 20 canbe designed to provide a full, or near full, erect firm penis byselecting harder durometer materials for the MC 22 and IC 24. Also,additional anchor locations at the mid and proximal shaft levels mightbe provided.

If an ED patient desires to have a balloon implant device placed, a PSD20 can be used simultaneously, but the PSD 20 placed on first. The PSD20 provides length and girth, while the balloon implant provides theerection function. Filler treatments may be needed to provide the“finishing touch” to hide any palpable components under the skin andalso to provide additional girth if needed. Note that the filler notonly provides for additional girth and assists making the PSD 20 (andballoon implant, if used) feel better to the touch, but also thisthickened skin, as a result of the filler treatment, diverts pressureoff of the internal devices (from external “hand” or “vaginal” forcestouching the now thickened skin), promotes stability, results in lessstress placed directly on the devices, and less stress and irritation onthe skin tissue as well.

When a patient is evaluated for ED and/or an enlargement procedure,there are several factors that need to be discussed. If the patient hasED, then the root cause needs to found (internal medicine and/or Urologydepartments for patient evaluation). If ED continues, even after, forexample, the Diabetes has been under control, then the patient can thentry medication/device therapy (pills, injections, suppositories, penispumps, etc.). If the medication/penis pump device treatment does notwork (The penis pump will help draw blood into the penile cavernosaltissues, then when full, a rubber band is placed at the penile base areato keep the blood “in”. This may be a viable option in some patients),the patient is then evaluated for a cavernosal (balloon or metal rodimplant) or subcutaneous device (PSD 20). Although a cavernosal implantis usually preferred, the PSD 20 can be considered an alternative, asmentioned above, and if a penile pump was added, this may be abeneficial partnership. As mentioned previously, the IC 24 can be madeof a malleable metal material. This allows for not only upward anddownward bending, as needed for intercourse, but also provides foradditional hardness needed for the erection state.

If a patient has ED and wants enlargement, then a combination PSD 20 andpermanent filler treatments may suffice. If an erection is not firmenough, then a balloon/metal rod implant should be added.

If a patient does not have ED, then the PSD 20 in combination withpermanent filler treatments can possibly handle all of the patient'sdesires for increased girth and length.

Penile Stocking Insert 400

The subject disclosure also features a penile stocking insert 400effective for increasing a length of a penis in its flaccid or erectstate (FIGS. 11A-11I). The penile stocking insert may comprise anelongated tubular body having a proximal end and a distal end. In someaspects, the insert may be configured to be implanted into a penileshaft underneath a penile skin and sutured to a penile facial tissuelayer so that the insert can prevent or reduce shrinkage and elongate anappearance of the penis in its flaccid state, and can further elongatethe appearance of the penis in its erect state. In one embodiment, theproximal end may be disposed near a pubic bone and the distal end may bedisposed near a glans coronal rim of the penis. The distal end of thebody may be at an angle so as to abut against the curvature of the glanscoronal rim.

One of the unique and inventive technical features of the presentinvention is the elongated tubular body 405 constructed from an elasticmaterial. Without wishing to limit the invention to any theory ormechanism, it is believed that this technical feature of the presentinvention advantageously provides for a compressive force, typicallymild to moderate, to be applied evenly around the penile shaft, thuselongating the length of the penis without causing discomfort to theuser nor interfering with regular tasks and activities. None of thepresently known prior references or work has the unique inventivetechnical feature of the present invention.

In some embodiments, the present invention features a penile stockinginsert 400 effective for increasing a length of a penis in its flaccidor erect state. Preferably, the penile stocking insert 400 may be in anysuitable configuration to achieve elongation of the penis while beingmedically safe and comfortable to a user. Furthermore, the penilestocking insert 400 is preferably capable of expanding and flexing inmultiple directions without causing pain or discomfort to the user.

Referring now to FIGS. 11A-11I, in some embodiments, the penile stockinginsert 400 may comprise an elongated tubular body 405 having a proximalend 412 and a distal end 414 (FIGS. 11A-11C). In some embodiments, theexterior surface is convex and the interior surface is concave such thatthe body 405 has a circular cross-section when viewed from the proximalor distal end. The curvature of the body 410 may be similar to a surfacecurvature of the penis, which is advantageous in that it mimics thesubstantially round shape of the penis, thereby maintaining the naturalshape of the penis when the insert 400 is implanted. Without wishing tolimit the invention to a particular theory or mechanism, the insert 400may prevent or reduce shrinkage, and increase the length of the penis inits flaccid state. In addition, the insert 400 is capable of bending andexpanding with the penis as it also bends and becomes erect. Furtherstill, the insert 400 can increase the length of the penis in its erectstate.

In some other embodiments, the insert 400 may be sewn or attached to anytissue layer of the penis in order to function in accordance with thepresent invention. For example, the insert may be sewn to the Buck'sfascia and/or tunica albuginea to provide for an effective increase inflaccid penile length and for long term stability of the implanted body.However, other methods of attaching the insert to the penis may beutilized, such as stapling, gluing, and the like.

In preferred embodiments, the insert 400 may be configured to beimplanted into a penile shaft of the penis and underneath a penile skinsuch that the proximal end 412 is disposed near a pubic bone and thedistal end 414 is disposed near a glans coronal rim of the penis. (seeFIG. 11F) In some embodiments, the distal end may be at a diagonal angle414B (FIGS. 11C and 11E) when viewed from a left or right side of thepenis so as to abut against and conform to a curvature of the glanscoronal rim. In other embodiments, the distal end may be vertical 414A(FIGS. 11B and 11D). In some embodiments, the proximal end 412 may havea flat edge with rounded corners to allow for the insert to comfortablyrest against the pubic bone. Further still, the tubular body 405completely encloses around the penile shaft and is configured to apply acompressive force around the penile shaft, thus elongating the length ofthe penis. Preferably, the tubular body can bend upwardly or downwardlyand sideways to allow for complete movement of the insert.

In preferred embodiments, the tubular body may be constructed from aflexible, medical-grade elastic material capable of applying acompressive force around the penile shaft, yet stretchable to allow forerection of penis. For example, the tubular body may be constructed froma medical-grade flexible, stretchable, and soft type of silicone rubber.This flexible and stretchable material is advantageous in that allowsfor the insert to bend with the penis while maintaining its structure.To illustrate, when the insert is mounted, or sutured, the penis mayretract and if the material is too soft or pliable, the insert may bowout and protrude, which would make the insert visible through the penisskin. Further still, it is preferred that the material can stretch andexpand to accommodate a penis entering an erect state. In otherembodiments, the use of medical grade silicone may allow for the insertto be used for the duration of the user's lifetime.

Preferably, the ends of the tubular body have rounded tips. It iscritical that the hard edge, thereby ensuring that the insert iscomfortable to the user. Further, the ends of the insert may taper tothe rounded tips, which advantageously allows for easier insertion ofthe tubular body into the penis.

In some embodiments, the insert may have a length of about 3 to 6 inchesfrom the proximal end to the distal end. In one embodiment, the insertmay have a length of about 3-4 inches. In another embodiment, the insertmay have a length of about 4-5 inches. In yet another embodiment, theinsert may have a length of about 5-6 inches. This variance in lengthwill accommodate for natural variances in penile length as well asproviding a recipient of the insert with a variety of choices regardinga desired penile length. In yet other embodiments, the penile insert maybe manufactured to have an initial length of about 9-12 inches. Thepenile insert may then be cut down to size to fit each recipientindividually and to a desired penile length.

Preferably, the outer surface of the penile insert is convex, and theinterior surface is concaved. This can allow for the penile insert tohave a curvature similar to that of the penis such that the penileinsert can be flushed with the penis without causing discomfort to theuser.

In some embodiments, the elongated tubular body 405 can have a thicknessranging from about 0.5 to 3 mm, and taper to a rounded 1 mm end distallyand proximally. In other embodiments, the elongated tubular body 405 canhave an interior diameter ranging from 3-5 cm. The diameter may varyaccording to a patient's needs, and the desired compressive force. Insome embodiments, the elongated tubular body 405 has smooth interior andexterior surfaces.

According to some embodiments, the suture aperture 450 (FIGS. 11B-11C)may have a diameter of about 0.5 to 1.5 mm. For example, the diameter ofthe suture aperture is about 1.5 mm. However, it is to be understoodthat the insert is not to be limited to any of the aforementioneddimensions, and that one of skill in the art will select the appropriatedimensions to achieve the desired effects of the present invention.

In alternate embodiments, the body can be without suture apertures (seeFIGS. 11D-11E). In this alternative embodiment, the body may be sewn orattached to the Tunica Albuginea TA or other tissue layer of the penisby wrapping or tying sutures around the edges of the insert, by staplingthe body to the various tissue layers of the penis, by gluing the bodyto the various tissue layers of the penis, or the like.

Embodiments of the penile stocking insert 400 have been described hereinfor elongating the penis in its flaccid or erect state. Thus, it is afurther objective of the present invention to provide for methods ofimplementing the insert 400. According to some embodiments, the presentinvention features a method of increasing a length of a penis in itsflaccid or erect state. In some embodiment, the method may compriseimplanting, into a shaft of the penis and underneath the penile skin,the penile stocking insert 400 according to any of the embodimentsdescribed herein, and attaching the insert 400 to a facial tissue layerof the penis.

In some embodiments, the insert 400 is implanted into the penile shaftsuch that the tubular body 405 completely encloses around the penileshaft. Further still, the proximal end 412 may be disposed near a pubicbone and the distal end 414 may be disposed near a glans coronal rim ofthe penis. Preferably, the curvature of the body may be similar to thesurface curvature of the penis. In some embodiments, the insert 400 maybe attached to penis tissue via sutures. Without wishing to limit theinvention to a particular theory or mechanism, the insert 400 can applya compressive force around the penile shaft, thus elongating theappearance (i.e. length) of the penis, as well as preventing or reducingshrinkage of the penis in its flaccid state.

In one embodiment, the step of attaching the insert 400 to the facialtissue layer of the penis may comprise suturing through the tissue layernear the glans coronal rim of the penis and through suture apertures 450disposed at the distal end 414 of the tubular body. In some embodiments,the insert 400 may be attached to a facial layer of the Buck's fasciaand tunica albuginea.

According to some embodiments, the penile stocking insert 400 isconfigured to apply a constant inwardly-directed radial force on thepenile shaft, which results in keeping the flaccid and possibly theerect state lengthened. The force applied by the insert is aninwardly-directed radial or a squeezing force, whereas the insert ofU.S. Pat. No. 6,537,204 (Elist) shown in FIG. 32 applies a splint, or“pull and hold in place” force. In contradistinction, the penilestocking insert 400 has a complete tubular stretchy body, unlike theprior art, which shows a partial cylindrical structure.

The insert 400 can expand outwardly to allow the penis to become erect,otherwise the penis would be constricted and not expand in girth, whichwould be painful. The prior art teaches a C-shaped rigid insert that hasan opening at a joint area to allow for the penis become erect. Even ifthe prior art was a tubular insert, it would not be able to expandduring an erection since it is a rigid structure; instead, it would beconstrictive and cause pain and tissue damage to the penis. Furthermore,the thickness of the penile stocking insert 400 of the present inventionis very thin, relative to the much thicker thickness, due to its rigidnature, of the prior art.

In some embodiments, the penile stocking insert 400 can be placed on anoutstretched (pulled flaccid) penis and slip over Buck's Fascia BF ofthe penile shaft, after the penile skin has been “de-gloved” or pulleddown. The insert can remain in position and exert a mild to moderate“spandex” or “stocking” (inwardly-directed radial) type of compressiveforce. This is a key feature that distinguishes it from the prior art.This compressive force effect squeezes the penile shaft and provides theforce not only to keep the insert in a stable position, but also to keepthe penile shaft outstretched and lengthened in the flaccid and erectstates. The prior art does not exert any inwardly-directed radial“squeezing type” pressure force on the penile shaft. In fact, the priorart is free floating, so it must be sutured and mounted aggressivelyinto place. In some embodiments, the penile stocking insert 400 of thepresent invention may be optionally sutured to prevent the insert frompotentially slipping or rolling downwards on the shaft during physicalor sexual activity. The sutures, if desired, may be placed at or nearthe glans (or distal end) area.

Without desiring to limit the invention to a particular theory ormechanism, the penile stocking insert 400 can hold the flaccid penis ina full outstretched position and exert a form in an even cylindricalmanner to aid in maintaining the penis lengthened in the flaccid anderect states. In other words, the penile stocking insert 400 cancontinuously squeeze the penile shaft to lengthen.

As used herein, the term “about” refers to plus or minus 10% of thereferenced number.

Various modifications of the invention, in addition to those describedherein, will be apparent to those skilled in the art from the foregoingdescription. Such modifications are also intended to fall within thescope of the appended claims. Each reference cited in the presentapplication is incorporated herein by reference in its entirety.

Although there has been shown and described the preferred embodiment ofthe present invention, it will be readily apparent to those skilled inthe art that modifications may be made thereto which do not exceed thescope of the appended claims. Therefore, the scope of the invention isonly to be limited by the following claims. Reference numbers recited inthe below claims are solely for ease of examination of this patentapplication, and are exemplary, and are not intended in any way to limitthe scope of the claims to the particular features having thecorresponding reference numbers in the drawings. In some embodiments,the figures presented in this patent application are drawn to scale,including the angles, ratios of dimensions, etc. In some embodiments,the figures are representative only and the claims are not limited bythe dimensions of the figures. In some embodiments, descriptions of theinventions described herein using the phrase “comprising” includesembodiments that could be described as “consisting of”, and as such thewritten description requirement of claiming one or more embodiments ofthe present invention using the phrase “consisting of” is met.

REFERENCE CHARACTER AND ABBREVIATION DEFINITIONS

-   B bladder-   BF Buck's Fascia-   C-Lube Carboxymethylcellulose Gel Lubrication, CMC Gel-   CC Corpus Cavernosum-   COL collar on the MC-PROX and MC-DIST for coupling within    receptacles in INS-   CR Coronal Rim-   CS Corpus Spongiosum-   CT connecting tube of PSD-Volume Shift-   CSASM Corpus Spongiasum-   DA Deep Artery of Penis-   DDV Deep Dorsal Vein of Penis-   DF Dartos Fascia-   DN Dorsal Nerve-   DORA Dorsal Artery of Penis-   DT Delivery Technique-   ED Erectile Dysfunction-   EGM erect girth measurement-   ELDS erect length dorsal side measurement-   ELVS erect length ventral side measurement-   EOL erect overall length measurement-   EPG enhanced penile girth-   EPL enhanced penile length-   ES external sutures-   FBR foreign body reaction-   FP Fascial Plane-   F_(RI) Inwardly-directed radial force-   F_(RO) Outwardly-directed radial force-   FTZ Filler Transition Zone-   G glans-   HEG hyperextended girth measurement-   HELDS hyperextended length dorsal side measurement-   HELVS hyperextended length ventral side measurement-   HEOL hyperxtended overall length measurement-   IC Internal Component-   INS insert portion of PSD-Insert embodiment 20E-   MC Main Component-   MC-DIST distal portion of the PSD-Insert embodiment 20E-   MC-PROX proximal portion of the PSD-Insert embodiment 20E-   MC-T1 distal telescoping portion of the PSD-Telescoping Design    embodiment 20F-   MC-T2 proximal telescoping portion of the PSD-Telescoping Design    embodiment 20F-   MS mounting sutures-   P penis-   PB pubic bone-   PF penile fascia-   PPD penis with Peyronie's Disease-   PLQ plaque-   PR Prostate-   PS penile shaft-   PSCS penile shaft cross section-   PSD Penile Sleeve Device-   PSK penile skin-   PSK-D penile skin dermis-   PSK-E penile skin epidermis-   PSU penile skin underside-   R external reservoir for PSD-Volume Shift-   REC receptacles in INS for receiving collars COL of MC-PROX and    MC-DIST-   S suture-   SA Sinusoidal Architecture-   SCR scrotrum-   SDV Superficial Dorsal Vein of Penis-   SGA penile skin sub-glans area-   S-Lube Silicone Oil Lubrication-   SPK radial spokes in PSD-Volume Shift embodiment-   SS Subcutaneous Space-   T testicle-   TA Tunica Albuginea-   TT Tubular Tunnel-   U Urethra-   10 area in penile shaft that may be occupied with ligament & tissues    (FIG. 8E)-   20 PSD (also PSD-smooth)-   20A PSD-S-fold-   20A1 PSD-wave-fold-   20A2 PSD-Tight-S-   20B PSD-Collapsible-   20C PSD-Volume Shift-   20D PSD-Spoke-   20E PSD-Insert-   20F PSD-Telescoping Design-   22 MAIN COMPONENT-   22A distal end-   22B medial ventral area-   22C medial dorsal area-   22D proximal ventral end-   22DT rounded edges of proximal ventral end-   22E proximal end flange-   22EC proximal end flange collapsed area-   22ET rounded edges of proximal end flange-   22E′ proximal end flange of PSD-Collapsible-   22E″ proximal end flange of PSD-Volume Shift-   22F veiny-look/texture-   22G bumps-   22H tear reduction-   22I pocket space in Main Component between inner and outer layers-   22ID pocket space distal-   22IL pocket space lateral-   22W pocket space proximal-   22J dorsal mid-line slit-   22JG groove of slit-   22JT tongue of slit-   22L buckling spaces-   22M suture anchor locations on the penile tissue-   22N suture slits with “5-pattern box”-   22O proximal lateral V-Cut-   22OT proximal latera V-Cut rounded edges-   22P tapered distal end-   22Q proximal end flange pocket to receive IC proximal end flange-   22R U-shaped portion along ventral side of Main Component (FIGS.    9B-9C)-   22S bilayer (inner layer 22S1 and outer layer 22T1, FIG. 1H)-   22S1 inner layer-   22S2 inner layer inner surface-   22S3 inner layer outer surface-   22T1 outer layer-   22T2 outer layer inner surface-   22T3 outer layer outer surface-   22W single layer-   22Z distal lateral line slit-   22ZG slit groove-   22ZT slit tongue-   24 INTERNAL COMPONENT-   24A distal end-   24B body portion-   24C proximal ventral end-   24D proximal end flange-   24E proximal lateral V-Cut-   24F buckle zone-   24G suture slits with “5-pattern box”-   24GA additional suture slit locations-   24H dorsal V-cuts-   24HE dorsal V-cut edge-   24I ventral V-cuts-   24IE ventral V-cut edge-   24J second internal component-   24K proximal dorsal reception slit for the working distal end of    T-Device-   24L inner surface-   24M outer surface-   24N piping-   240 1 mm port slit for erect testing injections-   24′ Internal Component that is initially flat (FIG. 3C)-   26 new collagen layer promoted by filler treatment (FIG. 8A)-   28 Glans Gripper Device-   28A distal portion-   28B medial portion-   28C proximal portion-   28D pads-   30 T-Device-   30A handle-   30B curved working distal end-   40 Pubic Fascial Plane (FIG. 8E)-   50 Pubic Pocket (FIG. 8E)-   80 Suture Clip-   95I inner layer S-Folds of Main Component-   951′ inner layer wavy-folds of Main Component-   95I″ inner layer Tight-S folds of Main Component-   95O outer layer S-Folds of Main Component-   95O′ outer layer wavy-folds of Main Component-   95O″ outer layer Tight-S folds of Main Component-   400 PENILE STOCKING INSERT-   405 elongated tubular body-   412 proximal end-   414 distal end-   414A vertical distal end-   414B diagonal angle distal end-   450 suture aperture-   455 suture

While the invention has been described in detail and with reference tospecific examples thereof, it will be apparent to one skilled in the artthat various changes and modifications can be made therein withoutdeparting from the spirit and scope thereof.

1. A penile sleeve device configured for implantation in thesubcutaneous space of a patient's penis for enhancing or correctingpenis shape and size, treating low to moderate level erectiledysfunction, or correcting penis curvature or malformation, said penilesleeve device comprising: an elongated tubular section comprising aflexible elastomer for maintaining the penis outstretched in a flaccidor erect state, said elongated tubular section having a proximal endflange, configured for positioning near the pubic bone, and having atapered distal end, configured for positioning adjacent the glans of thepenis, said elongated tubular section being configured to be positionedaround the penile shaft in the subcutaneous space of the patient'spenis; and wherein said elongated tubular section comprises alongitudinal pocket formed between an outer layer and an inner layer ofsaid elongated tubular section and wherein said penile sleeve devicefurther comprises an elongated open-tubular section comprising a highdurometer silicone rubber material or a metal malleable alloy forproviding hardness and structural support features to said penile sleevedevice, said elongated open-tubular section being positioned within saidlongitudinal pocket such that said elongated open-tubular section is notin direct contact with the penile shaft.
 2. (canceled)
 3. The penilesleeve device of claim 1 wherein said proximal end flange comprises apocket space therein and wherein said elongated open-tubular sectioncomprises another proximal end flange and wherein said another proximalend flange is positioned within said proximal end flange of saidelongated tubular section when said elongated open-tubular section ispositioned within said longitudinal pocket, said elongated open-tubularsection being concealed within said outer layer.
 4. (canceled)
 5. Thepenile sleeve device of claim 1 wherein said elongated tubular sectionand said elongated open-tubular section each comprise a respectivebuckle zone at a proximal end of said respective dorsal portions, saidbuckle zones aligning to provide slack to said penile sleeve device whenthe penis is bent.
 6. The penile sleeve device of claim 1 furthercomprising a plurality of suture slits on sides of said elongatedtubular section, said plurality of suture slits being formed in saidinner layer of said elongated tubular section.
 7. (canceled)
 8. Thepenile sleeve device of claim 1 wherein said outer layer of saidelongated tubular section comprises vein features and bumps forsimulating the appearance of a penis shaft. 9.-11. (canceled)
 12. Thepenile sleeve device of claim 1 wherein a ventral side of said elongatedtubular section comprises a U-shaped portion along its entire length,said U-shaped portion permitting urinary flow when the penis is in theflaccid and erect states. 13.-21. (canceled)
 22. A method for forming apenile sleeve device configured for implantation in the subcutaneousspace of a patient's penis for enhancing or correcting penis shape andsize, treating low to moderate level erectile dysfunction, or correctingpenis curvature or malformation, said method comprising: (a) forming anelongated tubular section from a flexible elastomer for maintaining thepenis outstretched in a flaccid or erect state, said forming furthercomprising forming a flange, configured for positioning near the pubicbone, at a proximal end of said elongated tubular section while forminga tapered portion, configured for positioning adjacent the glans of thepenis, on a distal end of said elongated tubular section. (b) forming anelongated open-tubular section comprising a high durometer siliconerubber material or a metal malleable alloy for providing hardness andstructural support features to said penal sleeve device, said elongatedopen-tubular section comprising a proximal end flange; and (c) insertingsaid elongated open-tubular section, through a dorsal mid-line slitformed in said outer layer, within said longitudinal pocket between saidouter layer and said inner layer of said elongated tubular section toprevent said elongated open-tubular section from making direct contactwith the penile shaft, said proximal end flange of said elongatedopen-tubular section being positioned within a pocket space within saidflange at said proximal end of said elongated tubular section. 23.-27.(canceled)
 28. The method of claim 22 wherein said step of forming saidelongated tubular section comprises forming vein features and bumps insaid outer layer for simulating the appearance of a penile shaft.29.-30. (canceled)